MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER KIT; NRY

Catalog Number	5MAXACE064KIT-A
Medical Device Problem Codes	Kinked (1339); Device Handling Problem (3265)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the penumbra system ace 64 reperfusion catheter (ace 64) was kinked approximately 72.0, 93.0, and 103.0 cm from the hub.Conclusions: evaluation of the returned device revealed it was kinked in multiple locations along its length.This type of damage typically occurs due to forceful manipulation at extreme angles during removal from the packaging or preparation for use.Ace 64 devices are 100% visually inspected during in-process inspection.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, while removing the penumbra system ace 64 reperfusion catheter (ace 64) from its packaging, the physician inadvertently kinked the distal end of the ace 64.The ace 64 became kinked prior to use and therefore, was not used for the procedure.The procedure was completed using a new ace 64 kit.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report: 1.Narrative/corrected.Results: the penumbra system ace 64 reperfusion catheter (ace 64) was kinked approximately 72.0, 93.0, and 103.0 cm from the hub and kinked on the distal tip.

• Brand Name: PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER KIT
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5710951
• Report Number: 3005168196-2016-00780
• Device Sequence Number: 477495
• Product Code: NRY
• UDI-Device Identifier: 00814548016481
• UDI-Public: 00814548016481
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K152541
• 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,Followup
• Report Date (Section B): 05/12/2016
• Report Date (Section F): 01/01/2005

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: Physician
• Device Expiration Date: 10/07/2018
• Device Catalogue Number: 5MAXACE064KIT-A
• Device Lot Number: F65979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2016
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/12/2016
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 06/09/2016
• Supplement Report FDA Received Date: 05/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005