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

Catalog Number	5MAXACE064KIT
Medical Device Problem Codes	Break (1069); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/11/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the penumbra system ace 64 reperfusion catheter (ace 64) was delaminated approximately 57.0, 87.0, 101.0, 110.0, and 111.0 cm from the hub, stretched approximately 113.0 cm from the hub, and fractured approximately 115.0 cm from the hub.Conclusions: evaluation of the returned device revealed the ace 64 was delaminated, stretched, and fractured.This damage may have occurred due to improper handling during removal from the packaging.If the ace 64 is withdrawn from the packaging shell prior to removing the tubing tray, damage such as this may occur.Penumbra catheters are inspected during in-process inspection and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 physician noticed the distal tip of a penumbra system ace 64 reperfusion catheter (ace 64) became damaged while removing it from the packaging.Upon inspection, the tip of the ace 64 was found loose and after further inspection, the distal tip separated from the rest of the ace 64.The tip of the ace 64 broke prior to use and therefore the ace 64 was not used in the procedure.The procedure was completed using a new ace 64.

• Brand Name: PENUMBRA SYSTEM ACE 64 HI-FLOW KIT
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6084337
• Report Number: 3005168196-2016-01573
• Device Sequence Number: 611808
• Product Code: NRY
• UDI-Device Identifier: 00814548016467
• UDI-Public: 00814548016467
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K152541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/11/2016

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: Physician
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 5MAXACE064KIT
• Device Lot Number: F68724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2016
• Initial Report FDA Received Date: 11/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1