MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG CMPLX XTRASOFT COIL 2.5X5; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640CX2505
Medical Device Problem Codes	Stretched (1601); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, weight, race, and ethnicity were not provided.Procode is krd/hcg.The expiration date of the device is not known as the device lot number is not available / not reported.The initial reporter phone:(b)(6).The initial reporter email address is not available / was not reported.The device 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 device manufacture date is not known as the device lot number is not available / not reported.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2021-00609.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
The healthcare professional reported that during endovascular aneurysm coil embolization procedure, the 150cm x 5cm prowler select lpes microcatheter (606s155x / unknown lot) was placed in the anterior communicating artery (acom) aneurysm then the 2.5mm x 5cm orbit galaxy complex xtrasoft coil (640cx2505 / unknown lot) was used to coil the target aneurysm.It was reported that the complaint coil got stuck in the microcatheter.The coil was removed, but it was observed stretched.As a result, the microcatheter and coil were both removed.Another microcatheter was placed and the aneurysm was coiled.The reported event resulted in a 20-minute procedure delay.The coil was removed easily without additional intervention, the procedure was successfully completed.It was reported that the patient is doing fine.There was no report of any adverse event or complication.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product was received the product analysis lab on 24-mar-2022.The return product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2021-00608 and 3008114965-2021-00609.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.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that multiple attempts to obtain additional information related to the procedure, the reported device issue, and to obtain the product for analysis were unsuccessful.If additional information is available at a later date and the product is returned, the file will be updated accordingly.The product investigation will be closed as no further investigation can be performed at this time.If the product is returned or additional information is provided at a later date, the file will be updated and a supplemental 3500a report will be submitted.[conclusion]: the healthcare professional reported that during endovascular aneurysm coil embolization procedure, the 150cm x 5cm prowler select lpes microcatheter (606s155x / unknown lot) was placed in the anterior communicating artery (acom) aneurysm then the 2.5mm x 5cm orbit galaxy complex xtrasoft coil (640cx2505 / unknown lot) was used to coil the target aneurysm.It was reported that the complaint coil got stuck in the microcatheter.The coil was removed, but it was observed stretched.As a result, the microcatheter and coil were both removed.Another microcatheter was placed and the aneurysm was coiled.The reported event resulted in a 20-minute procedure delay.The coil was removed easily without additional intervention, the procedure was successfully completed.It was reported that the patient is doing fine.There was no report of any adverse event or complication.Multiple attempts to obtain additional information related to the procedure, the reported device issue, and to obtain the product for analysis were unsuccessful.If additional information is available at a later date and the product is returned, the file will be updated accordingly.Based on complaint information, the device is not available to be returned for analysis.The device lot number was not available.The manufacturing documentation review could not be performed without the lot number.The device has not been returned for analysis and therefore, no further investigation can be performed at this time.As a result, we are closing this investigation.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.With the limited information available and without the product available for analysis, the reported customer complaint could not be confirmed.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction, aneurysm size / vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported issue.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.Updated sections: b.4, g.3, g.6, h.2, h.6, and h.10.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2021-00609.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.
Additional 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 endovascular aneurysm coil embolization procedure, the 150cm x 5cm prowler select lpes microcatheter (606s155x / 30541254) was placed in the anterior communicating artery (acom) aneurysm then the 2.5mm x 5cm orbit galaxy complex xtrasoft coil (640cx2505 / 30530433) was used to coil the target aneurysm.It was reported that the complaint coil got stuck in the microcatheter.The coil was removed, but it was observed stretched.As a result, the microcatheter and coil were both removed.Another microcatheter was placed and the aneurysm was coiled.The reported event resulted in a 20-minute procedure delay.The coil was removed easily without additional intervention, the procedure was successfully completed.It was reported that the patient is doing fine.There was no report of any adverse event or complication.Multiple attempts to obtain additional information related to the procedure and the reported device issue were unsuccessful.If additional information is received at a later date, this file will be updated accordingly.The complaint device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: a non-sterile 2.5mm x 5cm orbit galaxy complex xtrasoft coil was received.The lot number of the device is 30530433.Visual inspection was performed.The hypotube of the returned orbit galaxy complex was observed to be bent at 14 in.From the proximal end.No other anomalies or apparent damages were observed.Microscopic inspection was performed.Under magnification, it was observed that the embolic coil was missing (i.E., it was not attached to the headpiece), and the headpiece was still inside the gripper.The detached embolic coil was not returned to the lab for analysis.Functional testing cannot be performed without the embolic coil component.The impeded and stretched conditions encountered during the procedure could not be evaluated in the lab since the embolic coil was missing.However, the primary failure mode appears to have been that the stretch resistant fiber broke while the coil was being stretched, then the coil unraveled and pulled free from the headpiece.However, it is difficult to determine the exact contributing factors that may have resulted in the observed failure mode.The bent observed in the hypotube could be related to the post-operative handling or shipping / decontamination process since this damage is not documented on the complaint.It is also possible that in attempt to overcome the immobility of the coil inside the microcatheter, undue force might have inadvertently been applied causing the hypotube to bend.Coil stretching is a known potential issue associated with the use of this device.The instructions for use (ifu) provides proper handling instructions for the device to prevent such issue from occurring.Stretching can occur during procedure handling where force may have been inadvertently applied.The complaint documented that the coil got stuck in the concomitant microcatheter; the complaint coil was removed from the patient as it was observed to be stretched.It is possible that force may have inadvertently been applied during the coil removal from the microcatheter which resulted in the coil stretching.The failure encountered during the procedure could be also related to the compressed condition observed on the returned prowler select lpes microcatheter.However, it could not be determined if this damage is secondary to an attempt to advance the coil rather than being a contributing factor.A review of manufacturing documentation associated with this lot (30530433) 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.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.It should be noted that product failure is multifactorial.The instructions for use do contain the following precaution: never advance, withdraw, or torque the delivery tube against resistance without first determining the cause of resistance under fluoroscopy.Manipulation of the delivery tube against resistance can cause damage and/or premature detachment of the coil.If unusual friction is noted within the infusion catheter, remove the detachable coil system.If friction is noted with any subsequent detachable coil system, carefully examine the detachable coil system and the infusion catheter for possible damage.Replace both if necessary.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.Updated sections: b.4, d.4, g.3, g.6.H.2, h.3, h.4, h.6, and h.10.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2021-00608 and 3008114965-2021-00609.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: OG CMPLX XTRASOFT COIL 2.5X5
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CODMAN & SHURTLEFF, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvarcar; juarez chihuahua 32574 ; MX 32574
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 949789-8687
• MDR Report Key: 13019451
• Report Number: 3008114965-2021-00608
• Device Sequence Number: 12002741
• Product Code: KRD
• UDI-Device Identifier: 10886704030652
• UDI-Public: 10886704030652
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K093973
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 640CX2505
• Device Catalogue Number: 640CX2505
• Device Lot Number: 30530433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2021
• Supplement Date Received by Manufacturer: 02/09/2022; 03/24/2022; 05/31/2022
• Initial Report FDA Received Date: 12/16/2021
• Supplement Report FDA Received Date: 02/09/2022; 03/24/2022; 05/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PROWLER SELECT LPES.
• Patient Sex: Male