MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PULSERIDER T, 3MM, 10MM ARCH; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number 211D

Device Problems Failure to Advance (2524); Difficult to Advance (2920)

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

Event Date 08/18/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, 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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

As reported by the field, during a coil embolization of a bifurcation aneurysm, a headway, terumo microcatheter (mc) was initially used to deliver a pulserider t, 3mm, 10mm arch (211d, 3051697712) but the device was not able to be advance through the hub of the microcatheter.The microcatheter was replaced with a prowler select plus (product/lot number unknown) but there was a resistance felt when the complaint device was advancing through the microcatheter.The complaint device was replaced with another same sized coil and the replaced coil was able to be delivered and implanted.The coil embolization was successful, and the procedure was completed.

Manufacturer Narrative

Product complaint (b)(4).Section b5: additional information received indicated that the concomitant devices functioned as expected.The replaced coil was able to be advanced successfully with the same prowler select.A continuous flush on the microcatheters was maintained.The device was removed from the patient without additional intervention.The target vessel/site being treated was the basilar artery.Section e1 - initial reporter phone: (b)(6).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Manufacturer Narrative

Product complaint #(b)(4).The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.

Manufacturer Narrative

Product complaint # (b)(4).Updated section on this medwatch report: b4, g3, g6, h2, h3, h6 and h10.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by the field, during coil embolization of a bifurcation aneurysm, a headway, terumo microcatheter (mc) was initially used to deliver a pulserider t, 3mm, 10mm arch (211d, 3051697712) but the device was not able to be advance through the hub of the microcatheter.The microcatheter was replaced with a prowler select plus (product/lot number unknown) but there was a resistance felt when the complaint device was advancing through the microcatheter.The complaint device was replaced with another same sized coil and the replaced coil was able to be delivered and implanted.The coil embolization was successful, and the procedure was completed.Additional information received indicated that the concomitant devices functioned as expected.The replaced coil was able to be advanced successfully with the same prowler select.A continuous flush on the microcatheters was maintained.The device was removed from the patient without additional intervention.The target vessel/site being treated was the basilar artery.A non-sterile unit pulserider t, 3mm, 10mm arch was received inside of a pouch.The device was inspected, and it was found that the fork section is damaged, however the implant was noted in good normal conditions, no other damages or anomalies were observed on the device.The pulserider t, 3mm, 10mm arch was attempted to be advance through the lab sample microcatheter, however due to the damaged condition observed on the fork section it was not possible, due this condition the functional test could not be performed.A manufacturing record evaluation (mre) was performed for the finished device 3051697712 number, and no non-conformances related to the malfunction were identified.Visual analysis of the returned sample revealed that the device is damaged at the fork section, due this condition the functional test could not be performed and the customer complaint regarding ¿delivery wire - pulse rider - impeded - in microcatheter with loss of cerebral target site¿ was confirmed.Also, a resistance/friction was felt during the advancement of the delivery wire through the introducer, due this condition, the customer complaint regarding ¿delivery wire - pulse rider - resistance/friction with no loss of cerebral target site¿ was confirmed.Based on the findings during the analysis, the customer complaint was confirmed.Impeded - in microcatheter is a potential complication associated with the use of this device.It should be noted that product failure is multifactorial.The instructions for use (ifu) do contain the following recommendations: ¿ never advance or apply torque against resistance without careful fluoroscopic assessment of the cause.Movement against resistance may result in damage to the vessel or the device.If the cause cannot be determined, withdraw the device from the patient and replace with a new device.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and the evidence presented by the returned device; however, it is possible that clinical and procedural factors, including device manipulation and device interaction, may have contributed to the reported failure and damages on the returned system.As part of cerenovus quality process all devices are manufactured, inspected, and released to approved specifications.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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.

Manufacturer Narrative

Product complaint # (b)(4).Complaint conclusion revised: as reported by the field, during coil embolization of a bifurcation aneurysm, a headway, terumo microcatheter (mc) was initially used to deliver a pulserider t, 3mm, 10mm arch (211d, 3051697712) but the device was not able to be advance through the hub of the microcatheter.The microcatheter was replaced with a prowler select plus (product/lot number unknown) but there was a resistance felt when the complaint device was advancing through the microcatheter.The complaint device was replaced with another same sized pulse rider and the replaced device was able to be delivered and implanted.The coil embolization was successful, and the procedure was completed.Additional information received indicated that the concomitant devices functioned as expected.The replaced coil was able to be advanced successfully with the same prowler select.A continuous flush on the microcatheters was maintained.The device was removed from the patient without additional intervention.The target vessel/site being treated was the basilar artery.A non-sterile unit pulserider t, 3mm, 10mm arch was received inside of a pouch.The device was inspected, and it was found that the fork section is damaged, however the implant was noted in good normal conditions, no other damages or anomalies were observed on the device.The pulserider t, 3mm, 10mm arch was attempted to be advance through the lab sample microcatheter, however due to the damaged condition observed on the fork section it was not possible, due this condition the functional test could not be performed.A manufacturing record evaluation (mre) was performed for the finished device 3051697712 number, and no non-conformances related to the malfunction were identified.Visual analysis of the returned sample revealed that the device is damaged at the fork section, due this condition the functional test could not be performed and the customer complaint regarding ¿delivery wire - pulse rider - impeded - in microcatheter with loss of cerebral target site¿ was confirmed.Also, a resistance/friction was felt during the advancement of the delivery wire through the introducer, due this condition, the customer complaint regarding ¿delivery wire - pulse rider - resistance/friction with no loss of cerebral target site¿ was confirmed.Based on the findings during the analysis, the customer complaint was confirmed.Impeded - in microcatheter is a potential complication associated with the use of this device.It should be noted that product failure is multifactorial.The instructions for use (ifu) do contain the following recommendations: ¿ never advance or apply torque against resistance without careful fluoroscopic assessment of the cause.Movement against resistance may result in damage to the vessel or the device.If the cause cannot be determined, withdraw the device from the patient and replace with a new device.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and the evidence presented by the returned device; however, it is possible that clinical and procedural factors, including device manipulation and device interaction, may have contributed to the reported failure and damages on the returned system.As part of cerenovus quality process all devices are manufactured, inspected, and released to approved specifications.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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.Complaint conclusion revised to reflect that the procedure was completed with another pulserider and not a coil.

• Brand Name: PULSERIDER T, 3MM, 10MM 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12406531
• MDR Text Key: 283150675
• Report Number: 3008114965-2021-00440
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 00859030005130
• UDI-Public: 859030005130
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 211D
• Device Lot Number: 3051697712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: HEADWAY MICROCATHETER, TERUMO.; UNKPROWLER.