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

Catalog Number	5MAXACE132KIT
Medical Device Problem Codes	Break (1069); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/05/2019
Type of Reportable Event	Serious Injury
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.(b)(4).
Event or Problem Description
The patient was undergoing a thrombectomy procedure using a penumbra system ace 60 reperfusion catheter (ace60).During the procedure, the physician advanced the ace60 over a guidewire and a non-penumbra microcatheter within a non-penumbra sheath to the target location at the base of the clot.The physician advanced the guidewire through the clot but was unable to advance the microcatheter past the base of the clot.The physician aspirated for 90 seconds with the ace60, and then attempted to retract the ace60.While retracting, the physician felt minimal resistance and the ace60 stretched and broke into two pieces.The physician used a snare device to remove the distal end of the ace60 and then discontinued the thrombectomy procedure.
Additional Manufacturer Narrative
Results: the returned ace60 was stretched from approximately 104.0 ¿ 129.5 cm from the hub.The ace60 was fractured on the stretched region approximately 112.5 cm from the hub.The total length of the device was approximately 149.0 cm.The distal tip of the ace60 was not deformed.Conclusions: evaluation of the returned ace60 revealed it was stretched and fractured on the distal end.If the catheter is retracted against resistance it will likely begin to stretch.If the device continues to be retracted against resistance, it may eventually fracture.The root cause of the resistance could not be determined.Further evaluation revealed the non-penumbra microcatheter was also deformed on its distal length.If these devices became pinned within distal patient anatomy, it may have contributed to the resistance causing the devices to become deformed.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.H3 other text : placeholder.

• 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: 8580002
• Report Number: 3005168196-2019-00874
• Device Sequence Number: 1587368
• 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: K161640
• 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): 04/05/2019
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 5MAXACE132KIT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/05/2019
• Supplement Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 05/03/2019
• Supplement Report FDA Received Date: 08/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Date Report Sent to FDA: 01/01/2005