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

Catalog Number	5MAXACE132KIT
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/12/2019
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.This report is associated with mfr report number: 3005168196-2019-01378.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using a penumbra system ace 60 kit and a unknown penumbra microcatheter.During the procedure, the physician made a successful pass using a penumbra system ace 60 reperfusion catheter (ace60) and the unknown penumbra microcatheter with a neuron max 6f 088 long sheath (neuron max).While attempting to make another pass, the physician was unable to advance the microcatheter through the ace60 and, therefore, the ace60 and the microcatheter were removed.The procedure was completed using a non-penumbra catheter and the same neuron max.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: there was no visible damage to the ace60.Conclusions: evaluation of the returned ace60 revealed an undamaged, functional device.The coagulated blood inside the hub of the catheter was flushed out during decontamination.During functional testing, a demonstration lantern and 3maxc were advanced through the returned ace60 and out of the distal tip without an issue.The coagulated blood inside the hub of the ace60 may have contributed to the inability to advance unknown penumbra microcatheter through the ace60 during the procedure.The unknown penumbra microcatheter was not returned for evaluation; therefore, the root cause of the reported complaint could not be determined.The microcatheter identified in the complaint was not returned to penumbra for evaluation.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.This report is associated with mfr report number: 1.(b)(4) 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: 8798404
• Report Number: 3005168196-2019-01377
• Device Sequence Number: 2484775
• 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): 06/18/2019
• 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: 02/25/2022
• Device Catalogue Number: 5MAXACE132KIT
• Device Lot Number: F88688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/18/2019
• Supplement Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 07/17/2019
• 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
• Patient Age: 72 YR
• Date Report Sent to FDA: 01/01/2005