MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER; NRY

Model Number	5MAXACE068KIT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned ace68 confirmed that the device was fractured.The fractured catheter was held together by a small piece of polymer and the coil winds.Based on the damage near the fracture site, this catheter break was likely the result of a kink.If the device is forcefully manipulated against resistance or is otherwise mishandled at extreme angles during use, damage such as a kink and subsequent fracture 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
The patient was undergoing a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a penumbra system ace 68 reperfusion catheter (ace68), velocity delivery microcatheter (velocity), penumbra engine (engine), penumbra engine canister (canister), non-penumbra sheath and guidewire.During the procedure, the physician reached the target location with the ace68.When aspiration was turned on, the ace69 did not appear to be aspirating properly, but there was occasional blood coming back.The physician then removed the ace68 to see if the clot was ingested.At this point, the physician noticed the ace68 had almost broke about 10in from the distal tip but was hanging.Therefore, the ace68 was not used for the remainder of the procedure.The procedure was completed by using a penumbra system 5max reperfusion catheter (5maxc).There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11620503
• Report Number: 3005168196-2021-00695
• Device Sequence Number: 3262757
• Product Code: NRY
• UDI-Device Identifier: 00814548016603
• UDI-Public: 00814548016603
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• 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): 03/10/2021
• Report Date (Section F): 01/01/2005

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: 09/15/2022
• Device Model Number: 5MAXACE068KIT
• Device Catalogue Number: 5MAXACE068KIT
• Device Lot Number: F93120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 04/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Date Report Sent to FDA: 01/01/2005