MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PULSERIDER T, 3MM, 8MM ARCH; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number 201D

Device Problem Separation Failure (2547)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/24/2022

Event Type  malfunction  

Event Description

The healthcare professional reported that during a pulserider-assisted coil embolization procedure targeting an aneurysm at the distal basilar artery, a pulserider t shape, 8mm , 2.7 ¿ 3.5mm aneurysm neck reconstruction device (anrd) (201d / 3074237310) was used.A 7fr shuttle® guiding sheath (cook medical) was placed at the origin vertebral artery (va).From there, two intermediate catheters, a guidepost® distal access catheter (tokai medical) and a tactics intermediate catheter (technocrat corp) were delivered to the va union as distal access catheter (dac).The pulserider anrd was advanced via a (b)(4) (medtronic) and the pulserider was deployed antegraded.The pulserider anrd was implanted as the first attempt.An sl-10® microcatheter (stryker) was delivered via transcell and embolization was completed with ten (10) coils.The pulserider accessory cable (prdsacd / 30393940) was connected to a detachment control box and the red cable was connected to the delivery wire of the pulserider anrd and the black cable was connected by inserted a sterilized 20g (gauge) needle into the femur.The first attempt at detachment was made but the red light was flashing and an error was displayed.The puncture site was changed and the physician made another attempt to detach but the error reoccurred.The detacher and the cable were replaced.The rebar 18 microcatheter was delivered near the neck and the detachment was done.The delivery wire and the microcatheter were removed and the procedure completed.There was no negative impact to the patient.A continuous flush was maintained during the procedure.The pulserider stent remains implanted; the delivery wire is available to be returned.On 05-sep-2022, additional information was received.The information indicated that a pre-deployment electrical check was performed.During the detachment cycle, the detachment light did not illuminate and the audible signal beep was not heard.All connections fit properly without application of force.The reported issue did not result in any clinically significant delay in the procedure.On 07-sep 2022, the cerenovus sales representative provided additional information.The information indicated that the physician performed a self-test of the detachment controller according to the instructions for use (ifu) and confirmed that the detachment controller worked correctly and charging was sufficient.The physician also confirmed the connection by pushing the cable all the way into the detachment controller.The physician kept pushing the detachment button until the green light was flashing and then released the hand after the green light flashed.A few seconds later, the red light began to flash (the detachment error occurred).The information indicated that the detachment controller and the cables are not available to be returned for investigation, only the pulserider delivery wire is available.Photos of the complaint device were included in the file by the japan affiliates.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.The initial reporter phone: (b)(6).The initial reporter email address is not available / reported.The stent component remains implanted and is not available for return.The remainder of the device component is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.The product analysis lab reviewed the photos included in the complaint file by the japan affiliates.[photo review]: pre-shipment photos were attached to the complaint.It can be noted that only the delivery wire was returned for evaluation.Two kinked areas can be noted on it.In addition, it was noted that the pulserider implant was in a detached state.No other damages can be observed.A review of manufacturing documentation associated with this lot (3074237310) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The issue reported in the complaint could not be evaluated based on the photos.If the product is received after this photo review, an assessment will be performed as per the condition of the complaint device received.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product analysis lab received the complaint device on 05-oct-2022.A supplemental 3500a report will be submitted once the product investigation has been completed.Updated sections: b.4, d.9, g.3, g.6.H.2, h.3, h.6, and h.10.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that during a pulserider-assisted coil embolization procedure targeting an aneurysm at the distal basilar artery, a pulserider t shape, 8mm , 2.7 ¿ 3.5mm aneurysm neck reconstruction device (anrd) (201d / 3074237310) was used.A 7fr shuttle® guiding sheath (cook medical) was placed at the origin vertebral artery (va).From there, two intermediate catheters, a guidepost® distal access catheter (tokai medical) and a tactics intermediate catheter (technocrat corp) were delivered to the va union as distal access catheter (dac).The pulserider anrd was advanced via a rebar¿ 18 microcatheter (medtronic) and the pulserider was deployed antegraded.The pulserider anrd was implanted as the first attempt.An sl-10® microcatheter (stryker) was delivered via transcell and embolization was completed with ten (10) coils.The pulserider accessory cable (prdsacd / 30393940) was connected to a detachment control box and the red cable was connected to the delivery wire of the pulserider anrd and the black cable was connected by inserted a sterilized 20g (gauge) needle into the femur.The first attempt at detachment was made but the red light was flashing and an error was displayed.The puncture site was changed and the physician made another attempt to detach but the error reoccurred.The detacher and the cable were replaced.The rebar 18 microcatheter was delivered near the neck and the detachment was done.The delivery wire and the microcatheter were removed and the procedure completed.There was no negative impact to the patient.A continuous flush was maintained during the procedure.The pulserider stent remains implanted; the delivery wire is available to be returned.On 05-sep-2022, additional information was received.The information indicated that a pre-deployment electrical check was performed.During the detachment cycle, the detachment light did not illuminate and the audible signal beep was not heard.All connections fit properly without application of force.The reported issue did not result in any clinically significant delay in the procedure.On 07-sep-2022, the cerenovus sales representative provided additional information.The information indicated that the physician performed a self-test of the detachment controller according to the instructions for use (ifu) and confirmed that the detachment controller worked correctly and charging was sufficient.The physician also confirmed the connection by pushing the cable all the way into the detachment controller.The physician kept pushing the detachment button until the green light was flashing and then released the hand after the green light flashed.A few seconds later, the red light began to flash (the detachment error occurred).The information indicated that the detachment controller and the cables are not available to be returned for investigation, only the pulserider delivery wire is available.Photos of the complaint device were included in the file by the japan affiliates.The product analysis lab reviewed the photos included in the complaint file by the japan affiliates.[photo review]: pre-shipment photos were attached to the complaint.It can be noted that only the delivery wire was returned for evaluation.Two kinked areas can be noted on it.In addition, it was noted that the pulserider implant was in a detached state.No other damages can be observed.A review of manufacturing documentation associated with this lot (3074237310) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The issue reported in the complaint could not be evaluated based on the photos.The complaint device was returned for evaluation and analysis.The investigation finding is documented below.Investigation summary: a non-sterile pulserider t shape, 8mm , 2.7 ¿ 3.5mm anrd was received contained in the decontamination pouch.Visual inspection was performed.It was noted that consistent with the photos, only the delivery wire was returned for evaluation, and no damages were found on it.In the pre-shipment pictures, two kinked conditions can be appreciated on the delivery wire; however, these damages were not found in the returned device, is suspected that when the device was coiled for shipping, these got softened and straight up.The entire delivery wire length was inspected under a microscope, and no damages were found (i.E., no kinks, no bents, or fractures).Functional analysis cannot be performed with only delivery wire was returned for evaluation and the reported issue documented in the complaint regarding failure to detach could not be evaluated.Factors not described in the information provided, such as patient¿s anatomy, device manipulation, and operator¿s technique, may have contributed to the issue encountered rather than the device's manufacture.There is no indication that the issue reported in the complaint results from a defect inherently related to the device.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) does contain the following recommendation: ¿ increased detachment time may occur when the delivery wire and microcatheter markers are not properly positioned, there is improper setup of continuous flush, embolic coils are present, or connections between detachment power supply and delivery wire or patient¿s groin (return electrode) are poor.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.H.6: the code ¿no findings available¿ was used in the investigation findings because only the delivery wire component was returned; functional testing could not be conducted.The reported issue documented in the complaint regarding failure to detach could not be evaluated through functional evaluation.This code corresponds with the ¿cause not established¿ in the investigation conclusions.Updated sections: b.4, g.3, g.6.H.2, h.3, h.6, and h.10.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• Brand Name: PULSERIDER T, 3MM, 8MM ARCH
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CODMAN & SHURTLEFF, INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15398149
• MDR Text Key: 306434641
• Report Number: 3008114965-2022-00568
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 00859030005154
• UDI-Public: 859030005154
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: H160002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 201D
• Device Lot Number: 3074237310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GUIDEPOST® DISTAL ACCESS CATHETER (TOKAI MEDICAL); PULSERIDER ACCESSORY CABLES; REBAR¿ 18 MICROCATHETER (MEDTRONIC); SHUTTLE® GUIDING SHEATH (COOK MEDICAL); SL-10® MICROCATHETER (STRYKER); TACTICS INTERMEDIATE CATHETER (TECHNOCRAT CORP)