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

Model Number 201-D

Device Problem Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, ethnicity, and medical history were not provided.The initial reporter¿s first name and phone are not available / reported.The device component is available to be returned for evaluation and testing.If the device returns, a device investigation will be performed.A review of manufacturing documentation associated with this lot w3535-21 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 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.

Event Description

The healthcare professional reported that during the procedure targeting a 5.5mm aneurysm on the left anterior communicating artery bifurcation, the pulse-rider t, 3mm, 8mm arch aneurysm neck reconstruction device (201d / w3535-21) was delivered to the target position using the via¿ 21 microcatheter (microvention-terumo) failed to detach.Two pulse-rider accessory cables (prdsacd) from the same lot (30393939) were used with a 21, 19, and 18-gauge needles.The routine detachment cycle was performed with the pulse-rider detachment control box (prdscbd / 186280).It was reported that detachment was delayed about 10 minutes but the pulse-rider device detached through manual manipulation of the pulse-rider delivery wire.The detachment control box did not show a ¿fault¿ when connected to the arnd system.Deployment was confirmed by slowly pulling back on the delivery wire while watching to see if the implant moves.There was no report of any patient adverse event, or complication.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product analysis lab received the returned complaint device on 10/26/2020.The return product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.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 the procedure targeting a 5.5mm aneurysm on the left anterior communicating artery bifurcation, the pulserider t, 3mm, 8mm arch aneurysm neck reconstruction device (anrd) (b)(6) was delivered to the target position using the via¿ 21 microcatheter (microvention-terumo) failed to detach.Two pulserider accessory cables (prdsacd) from the same lot (30393939) were used with a 21, 19, and 18-gauge needles.The routine detachment cycle was performed with the pulserider detachment control box (b)(6).It was reported that detachment was delayed about 10 minutes but the pulserider device detached through manual manipulation of the pulserider delivery wire.The detachment control box did not show a ¿fault¿ when connected to the arnd system.Deployment was confirmed by slowly pulling back on the delivery wire while watching to see if the implant moves.There was no report of any patient adverse event or complication.The complaint device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the non-sterile pulserider t, 3mm, 8mm arch aneurysm neck reconstruction device was returned contained in a pouch.Visual inspection was performed.The returned device was observed to be in good, normal condition.The implant component was not returned.The complaint documented that the the pulserider implant was detached through manual manipulation.Functional testing could not be performed without the pulserider implant component.A review of manufacturing documentation associated with this lot w3535-21 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 complaint documented that the pulserider t, 3mm, 8mm arch anrd was delivered to the target position but failed to detach.Two pulserider accessory cables were used.The routine detachment cycle was performed with the pulserider dcb, but the pulserider device did not detach.The failure to detach issue could not be confirmed through functional testing as the pulserider implant was not returned.It was reported that the implant was detached through manual manipulation of the pulserider delivery wire.The exact cause of the reported failure to detach issue could not be confirmed.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.The concomitant pulserider accessory cables and the pulserider dcb were returned and also underwent evaluation.The concomitant devices were found to function properly.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.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
• MDR Report Key: 10709025
• MDR Text Key: 212579539
• Report Number: 3008114965-2020-00445
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 00859030005154
• UDI-Public: 00859030005154
• Combination Product (y/n): N
• PMA/PMN Number: H160002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2021
• Device Model Number: 201-D
• Device Catalogue Number: 201D
• Device Lot Number: W3535-21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Date Manufacturer Received: 11/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PULSERIDER ACCESSORY CABLES; PULSERIDER ACCESSORY CABLES; PULSERIDER DETACH CONTROL BOX; VIA¿ 21 MICROCATHETER (MICROVENTION-TERUMO)