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

Catalog Number	5MAXACE068KIT
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	12/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the penumbra system ace 68 reperfusion catheter (ace 68) was fractured approximately 58.5 cm from the hub.Conclusions: evaluation of the returned device revealed that the ace 68 was fractured.Although the complaint indicated that the damaged ace 68 was noticed prior to being taken out of the packaging, this type of damage typically occurs due to improper handling during removal from the packaging.If the ace 68 is forcefully removed from the packaging tray at extreme angles or if the aspiration tubing packaging tray is not removed prior to removing the ace 68, 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 that when the penumbra system ace 68 hi-flow kit (kit) was opened, the penumbra system ace 68 reperfusion catheter (ace 68) was broken before it was taken out of the packaging.The broken ace 68 was found prior to use and therefore, was not used in the procedure.The procedure was successfully completed using a new kit.

• 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: 6251695
• Report Number: 3005168196-2017-00061
• Device Sequence Number: 13566155
• Product Code: NRY
• UDI-Device Identifier: 00814548016597
• UDI-Public: 00814548016597
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K161640
• 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): 12/15/2016

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: 07/28/2019
• Device Catalogue Number: 5MAXACE068KIT
• Device Lot Number: F71659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2016
• Initial Report FDA Received Date: 01/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1