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

Catalog Number	5MAXACE132KIT
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.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 right middle cerebral artery (mca) using a penumbra system ace 60 reperfusion catheter (ace60), non-penumbra microcatheter, and non-penumbra stent retriever.During the procedure, the physician placed the microcatheter through the ace60 in the target vessel.Next, while advancing the stent retriever through the microcatheter, the physician experienced resistance.The physician then attempted to remove the microcatheter to increase aspiration power within the ace60, but the microcatheter became stuck inside the ace60; therefore, the physician removed the ace60, microcatheter, and stent retriever as a unit.The procedure was completed using another ace60 and a penumbra system 3max reperfusion catheter (3maxc).A thrombolysis in cerebral infarction (tici) grade 2b recanalization was then achieved.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the ace60 had a bend approximately 68.5 cm from the hub.Conclusions: evaluation of the returned ace60 revealed a bend in the catheter shaft which did not affect device functionality.This damage was likely incidental to the reported complaint.Further evaluation of the returned ace60 revealed that the non-penumbra microcatheter was able to be retracted out of the ace60 without an issue.The bend in the ace60 did not contribute to any resistance upon removal of the non-penumbra microcatheter from the ace60.The root cause of the reported non-penumbra microcatheter getting stuck within the ace60 could not be determined.No other devices associated with the complaint was returned for evaluation.Evaluation of the non-penumbra microcatheter revealed a functional device.The non-penumbra microcatheter was not damage.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 60 REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9490904
• Report Number: 3005168196-2019-02346
• Device Sequence Number: 19352730
• Product Code: NRY
• UDI-Device Identifier: 00814548017433
• UDI-Public: 00814548017433
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K160449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2019
• 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: 05/20/2022
• Device Catalogue Number: 5MAXACE132KIT
• Device Lot Number: F90441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/21/2019
• Supplement Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 01/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Date Report Sent to FDA: 01/01/2005