MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER; NRY

Catalog Number	5MAXACE064KIT
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/12/2019
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
During preparation for a thrombectomy procedure using a penumbra system ace 64 hi-flow kit (kit), the physician was unable to advance a guidewire through the penumbra system ace 64 reperfusion catheter (ace64) at the back table prior to insertion into the patient.Upon inspection, a kink was found at the proximal end of the ace64 and therefore, not used.The procedure was completed using a new ace64.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the ace64 was kinked approximately 3.5 cm, 51.0 cm and 90.0 cm from the hub.Conclusions: evaluation of the returned ace64 confirmed a kink near the hub.If the device is forcefully mishandled during preparation, damage such as a kink may occur.The kink likely contributed to the reported inability for the guidewire to advance through the ace64.During functional testing, the device was flushed with air while submerged in the bleach solution and air bubbles were seen exiting the kink indicating the device may have been punctured.If the guidewire is forcefully advanced into the ace64 against resistance, the catheter lumen may become punctured.The guidewire was not returned for evaluation.Further evaluation revealed additional bends.These bends were likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.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 64 REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8362818
• Report Number: 3005168196-2019-00328
• Device Sequence Number: 16611112
• Product Code: NRY
• UDI-Device Identifier: 00814548016467
• UDI-Public: 00814548016467
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K160449
• 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): 01/23/2019
• 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: 10/17/2020
• Device Catalogue Number: 5MAXACE064KIT
• Device Lot Number: F80025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/23/2019
• Supplement Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 02/22/2019
• Supplement Report FDA Received Date: 05/03/2019
• 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