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 Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/02/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
During preparation for a thrombectomy procedure, the hospital staff noticed that a penumbra system ace 64 reperfusion catheter kit (ace 64) was kinked upon removal from the packaging hoop.The kinked ace 64 was found prior to use and was not used for the procedure.The procedure was completed using a new ace 64.
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The device is no longer available for return.

• 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: 5538294
• Report Number: 3005168196-2016-00403
• Device Sequence Number: 272811
• Product Code: NRY
• UDI-Device Identifier: 00814548016481
• UDI-Public: 00814548016481
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2016

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: 09/29/2018
• Device Catalogue Number: 5MAXACE064KIT-A
• Device Lot Number: F65879
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/02/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/31/2016
• Supplement Report FDA Received Date: 08/17/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1