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

Model Number	5MAXACE132-A
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.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 m1 of the middle cerebral artery (mca) using a penumbra system ace 60 reperfusion catheter (ace60), non-penumbra 6f long sheath, non-penumbra microcatheter, and guidewire.It was noted that the patient had a tortuous vessel and a type iii aortic arch.During the procedure, while advancing an ace60 with the microcatheter over the guidewire, the ace60 would not advance past the ophthalmic artery.The physician then advanced the microcatheter and guidewire further and adjusted the ace60.After a few attempts, the ace60 was in position.Next, aspiration was initiated but no thrombus was being aspirated; therefore, the ace60 was removed.Upon removal, the ace60 was noticed to be kinked in the middle shaft.The procedure was completed using a navien catheter and a stent retriever device.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the returned ace60 was kinked approximately 91.0 cm from the hub.Conclusions: evaluation of the returned ace60 confirmed a kink.If the device is forcefully handled during preparation or is manipulated against resistance, the device may become kinked.The kink was not occlusive and functional testing revealed that the ace60 was able to aspirate.The other devices used in the complaint were not returned, therefore root cause of the reported complaint was unable to be determined.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 60 REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9477473
• Report Number: 3005168196-2019-02332
• Device Sequence Number: 19530597
• Product Code: NRY
• UDI-Device Identifier: 00814548017426
• UDI-Public: 00814548017426
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• 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): 11/19/2019
• 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: 09/04/2021
• Device Model Number: 5MAXACE132-A
• Device Catalogue Number: 5MAXACE132
• Device Lot Number: F85673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 01/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Date Report Sent to FDA: 01/01/2005