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

Model Number	5MAXACE068KIT
Medical Device Problem Codes	Break (1069); 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	09/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using penumbra system ace 68 reperfusion catheters (ace68), a neuron max 6f 088 long sheath (neuron max) and a penumbra system 3max reperfusion catheter (3maxc).During the procedure, the physician completed the first pass using the neuron max, ace68 and 3maxc.During the second pass, the physician experienced resistance while retracting the ace68 and subsequently, the ace68 separated at the midshaft; therefore, it was removed.The procedure was completed using another ace68, the same 3maxc and neuron max.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the returned ace68 was fractured at approximately 99.0 cm from the hub.Conclusions: evaluation of the returned ace68 confirmed a mid-shaft fracture.This damage is typically a result of forcefully retracting the device against resistance.If the device is retracted against resistance at an extreme angle outside the patient body, damage such as a kink and subsequently a 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.

• 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: 10690677
• Report Number: 3005168196-2020-01768
• Device Sequence Number: 3933387
• Product Code: NRY
• UDI-Device Identifier: 00814548016603
• UDI-Public: 00814548016603
• Combination Product (Y/N): Y
• Initial Reporter State: UT
• 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,Followup
• Report Date (Section B): 09/21/2020
• 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: 09/29/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/21/2020
• Supplement Date Received by Manufacturer: 10/16/2020
• Initial Report FDA Received Date: 10/16/2020
• Supplement Report FDA Received Date: 11/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Date Report Sent to FDA: 01/01/2005