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

Model Number	5MAXACE068
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the ace68 was kinked approximately 94.0 cm from the hub.The ace68 was stretched approximately 117.0 thru 122.0 cm from the hub.The total length was approximately 133.5 cm.Conclusions: evaluation of the returned ace68 revealed that the distal shaft of the catheter was stretched.This stretch is likely the reported ovalization.If the ace68 is forcefully manipulated against resistance during use, damage such as stretching may occur.During the functional test, the ace68 was connected to a demonstration canister and pump.The pump was powered on and the ace68 was able to aspirate fluid into the canister.Further evaluation of the returned ace68 revealed a kink in the distal shaft.This damage was likely incidental to the reported complaint and may have occurred during packaging of the device for return.Penumbra catheters are visually 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 right middle cerebral artery (mca) using a penumbra system ace 68 reperfusion catheter (ace68), non-penumbra sheath, balloon guide catheter, and penumbra system aspiration pump max 220 (pump max).During the procedure, the physician advanced the ace68 into the target location and turned on the pump max to initiate aspiration; however, it was noticed that the aspiration was low.Therefore, the ace68 was removed and the physician found the ace68 to be ovalized approximately 10 centimeters from the distal tip.The procedure was completed using a new ace68 with the same sheath, guide catheter, and pump max.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: 11201377
• Report Number: 3005168196-2021-00115
• Device Sequence Number: 16696903
• Product Code: NRY
• UDI-Device Identifier: 00814548016535
• UDI-Public: 00814548016535
• Combination Product (Y/N): Y
• Initial Reporter Country: KS
• PMA/510(K) Number: K161640
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/21/2020
• 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: 05/02/2022
• Device Model Number: 5MAXACE068
• Device Catalogue Number: 5MAXACE068
• Device Lot Number: F90059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2021
• 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: 12/21/2020
• Initial Report FDA Received Date: 01/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Date Report Sent to FDA: 01/01/2005