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

Catalog Number	5MAXACE064KIT-A
Medical Device Problem Codes	Leak/Splash (1354); Aspiration Issue (2883)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the penumbra system ace 64 reperfusion catheter (ace 64) was returned stuck to itself with a clear adhesive bandage.The ace 64 strain relief was kinked approximately 1.2 cm from the hub.The strain relief was unraveled by the penumbra investigator, and it was revealed that the ace 64 was fractured at the kink location.The clear adhesive bandage was removed by the penumbra investigator and the ace 64 was ovalized approximately 18.5 cm from the hub.Conclusions: evaluation of the returned device revealed that the ace 64 was fractured under the strain relief.This type of damage typically occurs due to improper handling during use.If the ace 64 is forcefully advanced or manipulated at an angle during insertion or positioning, damage such as a fracture may occur.Further evaluation revealed an ovalization on the proximal shaft of the ace 64.This ovalization was likely incidental, and may have occurred during packaging for return.Penumbra catheters 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
The patient was undergoing a thrombectomy procedure using a penumbra system ace 64 reperfusion catheter (ace 64).During the procedure, the physician noticed that the ace 64 was aspirating back air and was later leaking near the hub.However, the procedure was successfully completed without the use of a new ace 64 or another catheter.There was no report of an adverse effect to the patient.

• 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: 5689114
• Report Number: 3005168196-2016-00725
• Device Sequence Number: 18846284
• 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): 05/02/2016

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: Physician
• Device Expiration Date: 10/12/2018
• Device Catalogue Number: 5MAXACE064KIT-A
• Device Lot Number: F66018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2016
• Initial Report FDA Received Date: 05/31/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1