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

Model Number	5MAXACE132-A
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/28/2019
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 middle cerebral artery (mca) using a penumbra system ace 60 reperfusion catheter (ace60), non-penumbra microcatheter and guidewire.During the procedure, the ace60 was advanced with the microcatheter over the guidewire to the target location.Next, aspiration was initiated, but no thrombus was being aspirated after three attempts.Therefore, the ace60 was removed.Upon removal, it was noticed that the tip of the ace60 had collapsed.The procedure was completed using a stent retriever device.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the returned ace60 was damaged and had offset coil winds at approximately 127.5, 130.0, 132.5 and 133.0 cm from the hub.The distal tip was ovalized.Conclusions: evaluation of the returned ace60 was unable to confirm the reported complaint of being unable to aspirate.During functional testing, the ace60 was connected to a syringe and was able to aspirate water without an issue.The distal tip was confirmed to be ovalized.The observed damages did not affect device functionality.If the device is forcefully manipulated during preparation or during the procedure, damage such as an ovalization may occur.Further evaluation revealed damaged and offset coil winds.These damages were likely incidental to the reported complaint.No other devices mentioned in reported complaint were returned, therefore the cause of the reported complaint could not be identified.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: 9477572
• Report Number: 3005168196-2019-02334
• Device Sequence Number: 14141192
• 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: 01/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Date Report Sent to FDA: 01/01/2005