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

Catalog Number	5MAXACE068KIT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.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 m2 segment of the middle cerebral artery (mca) using a penumbra system ace 68 reperfusion catheter (ace68) and a non-penumbra guide catheter.During the procedure, the physician advanced the ace68 to the target vessel using the guide catheter and began aspiration.Subsequently, the physician noticed that the proximal end of the ace68 was broken and leaking.Therefore, the ace68 was removed.The procedure was completed using a penumbra system jetd reperfusion catheter (jetd) and the same non-penumbra guide catheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned ace68 confirmed, the reported complaint.Evaluation revealed, a kink near the hub distal to the strain relief.If the device is manipulated at an extreme angle, during use, damage such as this may occur.This damage likely contributed to the leaking, during the procedure.Further evaluation revealed, an ovalization on the distal shaft and kinks along the catheter.This damage was incidental to the reported complaint and may be incidental.During evaluation, a leak was observed, coming from the kinked location.And the ace68 was advanced through a demonstration neuron max with resistance, due to the ovalization on the distal shaft.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.H3 other text: placeholder.

• Brand Name: PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 15299136
• Report Number: 3005168196-2022-00391
• Device Sequence Number: 19406162
• Product Code: NRY
• UDI-Device Identifier: 00815948022850
• UDI-Public: 815948022850
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K161640
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2022
• 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: 12/14/2024
• Device Catalogue Number: 5MAXACE068KIT
• Device Lot Number: H12232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• 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: 08/03/2022
• Supplement Date Received by Manufacturer: 10/05/2022
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 11/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005