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

Catalog Number	5MAXACE064KIT-A
Medical Device Problem Codes	Leak/Splash (1354); Material Separation (1562); Aspiration Issue (2883)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/18/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the penumbra system ace 64 reperfusion catheter (ace 64) was fractured underneath the strain relief approximately 1.5 cm from the hub.Conclusions: evaluation of the returned device revealed that the ace 64 was fractured underneath the strain relief.This type of damage likely occurs due to improper handling during removal from the packaging hoop or during use.If the device is forcefully removed from the packaging hoop at an angle or if the device is forcefully manipulated during use, damage such as this may occur.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
The patient was undergoing a thrombectomy procedure using a penumbra system ace 64 kit (ace 64).During the entire procedure, the physician noticed that the ace 64 was separated around the hub and subsequently, it was leaking below the hub and sucking back air.However, the procedure was completed using the same ace 64.There was no report of an adverse effect to the patient.

• 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: 5671506
• Report Number: 3005168196-2016-00703
• Device Sequence Number: 49428
• 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): 04/22/2016

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: 10/07/2018
• Device Catalogue Number: 5MAXACE064KIT-A
• Device Lot Number: F65978
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2016
• Initial Report FDA Received Date: 05/23/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1