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 Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/27/2019
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 using penumbra system ace 68 reperfusion catheter (ace68).During the procedure, while inserting the ace68 to make an initial pass, the physician noticed the proximal end of the ace68 to be kinked.Therefore, the ace68 was removed.The procedure was completed using a new catheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the ace68 was kinked approximately 3.5, 9.5, 11.5 and 101.5 cm from the hub.Conclusions: evaluation of the returned ace68 confirmed that the catheter was kinked.If the ace68 is forcefully advanced against resistance at an extreme angle during use, damage such as a kink may occur.Further evaluation of the returned ace68 revealed an additional kink near the mid-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.

• 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: 10320302
• Report Number: 3005168196-2020-01008
• Device Sequence Number: 11557919
• Product Code: NRY
• UDI-Device Identifier: 00814548016535
• UDI-Public: 00814548016535
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K161640
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2020
• 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: 12/16/2021
• Device Model Number: 5MAXACE068
• Device Catalogue Number: 5MAXACE068
• Device Lot Number: F87543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/02/2020
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 07/24/2020
• Supplement Report FDA Received Date: 10/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005