MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER; NRY

Catalog Number	4MAXC
Medical Device Problem Codes	Kinked (1339); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the penumbra system 4max reperfusion catheter (4max) was kinked approximately 103.0 cm from the hub.Conclusion: evaluation of the returned device confirmed the penumbra system 4max reperfusion catheter (4max) was kinked.This damage may have occurred due to forceful manipulation of the 4max during preparation for use.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.
Event or Problem Description
During preparation for a thrombectomy procedure, the penumbra system 4max reperfusion catheter (4max) became kinked at the mid-shaft.The 4max was damaged prior to use and was not used for the procedure.The procedure was completed using another 4max.

• Brand Name: PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6755752
• Report Number: 3005168196-2017-01329
• Device Sequence Number: 121536
• Product Code: NRY
• UDI-Device Identifier: 00814548012414
• UDI-Public: 00814548012414
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K160449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/11/2017

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: 03/01/2020
• Device Catalogue Number: 4MAXC
• Device Lot Number: F74716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2017
• Initial Report FDA Received Date: 07/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1