MAUDE Adverse Event Report: PULSAR VASCULAR PULSERIDER T, 3MM, 10MM ARCH; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number 211D

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/02/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant med products: prowler select plus microcatheter (606s255x / 30006959).This is one of two products involved with the reported complaint.The associated manufacturer report numbers are: 3008680601-2018-00545 and 1226348-2018-00595.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.The device has not been returned.If the device returns, a device investigation will be performed.Additional information will be submitted within 30 days of receipt.

Event Description

The healthcare professional reported that during the procedure targeting the middle cerebral artery (mca) aneurysm, the pulserider t, 3 mm, 10 mm arch (211d / w3119-08) would not advance into the prowler select plus microcatheter (606s255x / 30006959).The physician switched the prowler select plus microcatheter for a new microcatheter and the pulserider device would not advance into the new microcatheter.The pulserider device was switched out for another of the same size and there was no issue with advancing the replacement pulserider device into the prowler select plus microcatheter.There was no report of patient consequence or complication.The reported event resulted in a 10- minute delay in the procedure; the procedure was successfully completed.

Manufacturer Narrative

Manufacturer¿s ref.(b)(4).Product was received and is pending evaluation.The manufacturer will submit a supplemental report once evaluation is completed.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).[conclusion]: the healthcare professional reported that during the procedure targeting the middle cerebral artery (mca) aneurysm, the pulserider t, 3 mm, 10 mm arch (211d / w3119-08) would not advance into the prowler select plus microcatheter (606s255x / 30006959).The physician switched the prowler select plus microcatheter for a new microcatheter and the pulserider device would not advance into the new microcatheter.The pulserider device was switched out for another of the same size and there was no issue with advancing the replacement pulserider device into the prowler select plus microcatheter.There was no report of patient consequence or complication.The reported event resulted in a 10- minute delay in the procedure; the procedure was successfully completed.Investigation summary: the aneurysm neck reconstruction device (anrd) is retracted into the introducer.The anrd was advanced out of the introducer.There is no apparent gross damage to the structure of the anrd.There are no apparent kinks or bends in the delivery wire.The arch is intact.The anchor is intact.There is a slight bend in one branch of the fork.The crimp connection between the fork and the delivery wire is intact.The anrd was retracted into the introducer, and the introducer was inserted into a lab rotating hemostatic valve (rhv) attached to a lab prowler select plus microcatheter.An attempt was made to advance the device through the microcatheter.The device successfully advanced through the microcatheter.Investigation conclusion: the complaint that the device was impeded in the microcatheter is not confirmed.The anrd passed through a lab microcatheter with no resistance.There is a slight bend in one branch of the fork section of the delivery wire.This suggests that an attempt may have been made to advance the device against some resistance.However, there was no damage to the anrd device and no cause for resistance is observed in the anrd device, delivery wire, or introducer.Device history lot: a review of manufacturing documentation associated with this lot (w-3119-08) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Manufacturing date: 2017-06-19.Original expiration date: 2019-06.Revised expiration date: 2020-05-28 (expiration date revised 2017-09-18).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, 10MM ARCH
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): PULSAR VASCULAR; 130 knowles dr suite e; los gatos CA 95032
• MDR Report Key: 7549637
• MDR Text Key: 109495193
• Report Number: 3008680601-2018-00545
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• 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: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2020
• Device Catalogue Number: 211D
• Device Lot Number: W3119-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Date Manufacturer Received: 05/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1