MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER; NRY

Model Number	5MAXACE068KIT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the right middle cerebral artery (mca) using a penumbra system ace 68 reperfusion catheter (ace68) and neuron max 6f 088 long sheath (neuron max).It was reported that the patient had an angioplasty and stent placed in the internal carotid artery (ica).During the procedure, the physician placed the neuron max north of the stent, advanced the ace68 through the neuron max, and performed aspiration using the ace68.The physician then observed that there was no flow coming out of the ace68 and pulled back the ace68.While retracting the ace68, the physician noticed a coil wind coming out of the distal end of the ace68; therefore, the neuron max was removed with the ace68.The ace68 was then pulled out of the neuron max on the back table.The procedure was completed after the removal of the ace68 as the vessel was opened.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10513200
• Report Number: 3005168196-2020-01419
• Device Sequence Number: 3869061
• Product Code: NRY
• UDI-Device Identifier: 00814548016603
• UDI-Public: 00814548016603
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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
• Report Date (Section B): 08/18/2020
• 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: 09/15/2022
• Device Model Number: 5MAXACE068KIT
• Device Catalogue Number: 5MAXACE068KIT
• Device Lot Number: F93120
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 09/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Date Report Sent to FDA: 01/01/2005