MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER; NRY

Catalog Number 3MAXC

Device Problems Failure to Advance (2524); Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/19/2019

Event Type  malfunction  

Manufacturer Narrative

The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a thrombectomy procedure in the basilar artery for acute cerebral infarction using penumbra system max 3 reperfusion catheter (3 maxc).During the procedure, the physician encountered resistance while inserting the guide wire into the 3 maxc and the 3 maxc was not used.It was reported that the 3 maxc could have been ovalized.The physician then inserted the guidewire into another 3 max; however, he could not catch the clot with it.The physician successfully completed the procedure by using the same 3 maxc and a penumbra system ace 68 reperfusion catheter (ace68).There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the 3maxc was kinked approximately 85.5 cm from the hub.The device was ovalized approximately 112.0 cm from the hub.Conclusions: evaluation of the returned 3maxc revealed a kink.If the device is forcefully advanced against resistance, damage such as a kink may occur.During functional testing, a demonstration guidewire was advanced through the 3maxc without an issue.The non-penumbra guidewire identified in the complaint was not returned for evaluation; therefore, the root cause of the resistance experienced during the procedure could not be determined.Further evaluation revealed an ovalization.This damage was likely incidental to the reported complaint.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.H3 other text : placeholder.

• Brand Name: PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8895485
• MDR Text Key: 154407548
• Report Number: 3005168196-2019-01563
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548012490
• UDI-Public: 00814548012490
• Combination Product (y/n): Y
• PMA/PMN Number: K160449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,07/16/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 01/21/2022
• Device Catalogue Number: 3MAXC
• Device Lot Number: F88087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 07/16/2019
• Initial Date FDA Received: 08/14/2019
• Supplement Dates Manufacturer Received: 08/19/2019
• Supplement Dates FDA Received: 08/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1