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

Catalog Number	5MAXACE064KIT
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	11/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the tubing tray component of the packaging shell was still intact with the returned packaging shell.The penumbra system ace 64 reperfusion catheter (ace 64) was kinked approximately 49.0 cm from the hub, and in multiple other locations along the catheter shaft.Conclusions: evaluation of the returned device revealed that it was kinked in multiple locations along the catheter shaft.This type of damage typically occurs due to improper handling during preparation for use.If the ace 64 is forcefully withdrawn from the packaging shell before the tubing tray is removed, damage such as this may occur.Some of the observed kinks were likely incidental and may have occurred due to improper handling during packaging of the device for return.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 hospital staff noticed that the penumbra system ace 64 reperfusion catheter (ace 64) had two kinks upon removal from the packaging.The kinked ace 64 was noticed prior to use and therefore, was not used for the procedure.The procedure was successfully completed using a new ace 64.

• Brand Name: PENUMBRA SYSTEM ACE 64 KIT
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6191572
• Report Number: 3005168196-2016-01846
• Device Sequence Number: 52888
• Product Code: NRY
• UDI-Device Identifier: 00814548016481
• UDI-Public: 00814548016481
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 11/23/2016

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: 10/18/2018
• Device Catalogue Number: 5MAXACE064KIT
• Device Lot Number: F66079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2016
• Initial Report FDA Received Date: 12/20/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1