MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE 68 HI-FLOW KIT; NRY

Catalog Number	5MAXACE068KIT-B
Medical Device Problem Codes	Crack (1135); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/23/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the penumbra system ace 68 reperfusion catheter (ace 68) was kinked approximately 62.0 cm from the hub.Conclusions: evaluation of the ace68 and the ace60 revealed that both devices were kinked.The type of damage observed on the ace 68 typically occurs due to improper handling during removal from the packaging.If the tubing tray is not removed prior to withdrawing the catheter from the packaging, damage such as this may occur.The damage observed on the ace60 may have occurred due to forceful manipulation of the ace60 during removal from the packaging or 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.This report is associated with mfr report numbers: 3005168196-2016-01506.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using a penumbra system ace 68 reperfusion catheter (ace 68) and a penumbra system ace 60 reperfusion catheter (ace 60).During the procedure, upon opening the ace 68 and ace 60 product boxes, the hospital staff noticed they were cracked within their product packagings.The cracked ace 68 and ace 60 were found prior to used and therefore were not used in the procedure.The procedure was completed using a new ace 60.

• Brand Name: PENUMBRA SYSTEM ACE 68 HI-FLOW KIT
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6057978
• Report Number: 3005168196-2016-01505
• Device Sequence Number: 1896954
• Product Code: NRY
• UDI-Device Identifier: 00814548017532
• UDI-Public: 00814548017532
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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
• Report Date (Section B): 09/26/2016

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: 02/22/2017
• Device Catalogue Number: 5MAXACE068KIT-B
• Device Lot Number: F70738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2016
• Initial Report FDA Received Date: 10/26/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1