MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER; NRY

Catalog Number	5MAXACE132
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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 middle cerebral artery (mca) using a penumbra system ace 60 reperfusion catheter (ace60).During the procedure, the physician advanced the ace60 and a non-penumbra microcatheter to the m1 segment and turned on aspiration for approximately 90 seconds and attempted to aspirate the thrombus several times; however, was unsuccessful.Therefore, the physician removed the ace60 and found the mid shaft to be ovalized.The procedure was then completed using a new ace60 and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the device associated with this complaint was initially expected not to be returned; however, additional information received from the distributor on 25 july 2019 indicated that the device was available for return.Results: the ace60 was stretched and ovalized from approximately 119.0 ¿ 131.5 cm from the hub.The total length of the ace60 was approximately 135.0 cm.Conclusions: evaluation of the returned ace60 revealed stretching and ovalization on the distal shaft.If the device is forcefully retracted against resistance, damage such as these may occur.The root cause of the resistance could not be determined.During functional testing, the ace60 was connected to a demonstration aspiration tubing and pump max and was able to aspirate liquid without an issue.The reported inability to aspirate could not be confirmed.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 60 REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8750205
• Report Number: 3005168196-2019-01248
• Device Sequence Number: 16654905
• Product Code: NRY
• UDI-Device Identifier: 00814548017426
• UDI-Public: 00814548017426
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K160449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2019
• 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: 05/30/2021
• Device Catalogue Number: 5MAXACE132
• Device Lot Number: F83742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/04/2019
• Supplement Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 07/01/2019
• Supplement Report FDA Received Date: 11/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Date Report Sent to FDA: 01/01/2005