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

Model Number	5MAXACE068KIT
Medical Device Problem Codes	Stretched (1601); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned ace68 confirmed that the device was stretched and ovalized on its distal shaft.This damage is typically a result of retracting the device against resistance.The root cause of the resistance could not be determined.Further evaluation of the device revealed a distal ovalization.This damage was likely incidental to the complaint.During functional testing, the ace68 was unable to advance into a demonstration neuron max due to the stretching on the distal shaft.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the internal carotid artery (ica) and m1 segment of the middle cerebral artery (mca) using a penumbra system ace 68 reperfusion catheter (ace68) and non-penumbra sheath.During the procedure, on the second pass under aspiration, the physician experienced slight resistance when pulling back the ace68.As the physician continued to pull back under aspiration, the ace68 stretched distally.The physician was able to remove the ace68.The procedure was completed using a new ace68 and the same sheath.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: 11326014
• Report Number: 3005168196-2021-00276
• Device Sequence Number: 16981063
• 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): 01/19/2021
• 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: 01/26/2021
• 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: 01/19/2021
• Initial Report FDA Received Date: 02/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Date Report Sent to FDA: 01/01/2005