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

Model Number	5MAXACE068
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976); 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	11/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Results: the ace68 was ovalized approximately 37.0 and 55.0 cm from the hub.The ace68 was stretched approximately 104.0 thru 132.0 cm from the hub.The ace68 was fractured approximately 116.0 cm from the hub.Conclusions: evaluation of the returned ace68 confirmed a fracture on the distal shaft and revealed that the device was stretched.If the ace68 is forcefully retracted against resistance, damage such as stretching, and a fracture may occur.The root cause of resistance could not be determined.Further evaluation of the returned ace68 revealed ovalization on the catheter shaft.This damage was likely incidental to the reported complaint.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 left internal carotid artery (ica) using a penumbra system ace 68 reperfusion catheter (ace68) and balloon guide catheter.During the procedure, the physician completed a pass using the ace68.While advancing the ace68 through the balloon guide catheter to make another pass, the physician experienced resistance in the internal carotid artery (ica); consequently, the ace68 became kinked at a steep angle and the ace68 would not advance any further.Subsequently, the physician confirmed the ace68 was still intact and decided to remove it; however, after removing the ace68, the physician noticed the middle to higher distal portion of the ace68 had broken off and detached inside the balloon guide catheter.Therefore, the physician removed the balloon guide catheter containing the detached portion of the ace68.The procedure was completed using another catheter and the same balloon guide catheter.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: 11015993
• Report Number: 3005168196-2020-02281
• Device Sequence Number: 17129750
• 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): 11/20/2020
• 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: 04/17/2023
• Device Model Number: 5MAXACE068
• Device Catalogue Number: 5MAXACE068
• Device Lot Number: F97380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• 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: 11/20/2020
• Initial Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 89 YR
• Date Report Sent to FDA: 01/01/2005