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

Catalog Number	5MAXACE064KIT-A
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	07/10/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: prior to decontamination, blood was observed on the penumbra system ace 64 reperfusion catheter (ace 64).The strain relief was offset.The strain relief was unwound by a penumbra investigator, and no further damage was observed under the strain relief.The ace 64 was kinked approximately 106.0 and 131.0 cm from the hub.Conclusions: evaluation of the returned device revealed blood was present on the catheter shaft, indicating it may have been used in the procedure.Further evaluation revealed the strain relief was offset, but there was no further damage under the strain relief.The ace 64 was flushed and no leakages were observed.Therefore, the observed strain relief offset does not affect the functionality of the ace 64, and the catheter shaft was undamaged.Further evaluation revealed the ace 64 was kinked.The kink located approximately 106.0 cm from the hub likely occurred due to return packaging conditions.The kink located 131.0 cm from the hub may have occurred due to improper handling of the ace 64 during preparation for the procedure.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, the hospital staff noticed that the penumbra system ace 64 reperfusion catheter (ace 64) was cracked at the hub upon removal from the packaging.The cracked ace 64 was found prior to use and therefore, was not used for 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: 5854669
• Report Number: 3005168196-2016-01125
• Device Sequence Number: 842138
• Product Code: NRY
• UDI-Device Identifier: 00814548016481
• UDI-Public: 00814548016481
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 07/11/2016

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: Health Professional
• Device Expiration Date: 03/25/2019
• Device Catalogue Number: 5MAXACE064KIT-A
• Device Lot Number: F68648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2016
• Initial Report FDA Received Date: 08/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1