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

Catalog Number	5MAXACE132KIT
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/01/2019
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 in the cerebral artery using a penumbra system ace 60 kit.During the procedure, the physician advanced a penumbra system ace 60 reperfusion catheter (ace60) with a non-penumbra sheath into the patient¿s body.While attempting to insert a penumbra system 3max reperfusion catheter (3maxc) into the ace60 and the sheath, the physician noticed that the proximal end of the ace60 was kinked; therefore, the ace60 was removed.The procedure was completed using another ace60 and the same 3maxc and sheath.There was no adverse effect to the patient.
Additional Manufacturer Narrative
Results: the penumbra system ace 60 reperfusion catheter (ace60) was kinked approximately 73.5 cm from the hub.The device was ovalized approximately 106.5 and 121.5 cm from the hub.Conclusions: evaluation of the returned ace60 confirmed a kink.If the device is forcefully mishandled during use, damage such as a kink may occur.The reported complaint did not mention resistance; therefore, the root cause of the kink could not be determined.During functional testing, resistance was experienced at the kinked location of the ace60 while attempting to advance a demonstration 3maxc through the ace60 and the catheter could not advance any further.Further evaluation revealed ovalizations.These damages 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.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: 8890536
• Report Number: 3005168196-2019-01574
• Device Sequence Number: 2587201
• Product Code: NRY
• UDI-Device Identifier: 00814548017433
• UDI-Public: 00814548017433
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2019
• 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: 02/13/2022
• Device Catalogue Number: 5MAXACE132KIT
• Device Lot Number: F88553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/16/2019
• Supplement Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 08/13/2019
• Supplement Report FDA Received Date: 08/27/2019
• 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