MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER; NRY

Catalog Number	5MAXACE064-A
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578); Difficult to Advance (2920)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	12/18/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Please note that dissection is a known and anticipated complication with these types of procedures and is noted in the device labeling.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.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a thrombectomy procedure for a cervical loop in the distal right m1 section of the internal carotid artery (ica) using a penumbra system ace 64 reperfusion catheter (ace 64).During the procedure, the first physician advanced another manufacturer's microcatheter through the loop without any issues and attempted to track the ace 64 through the loop but was unable to.A second physician then attempted to track the ace 64 but was also unsuccessful and indicated that there was a lot of wall tension.Since the microcatheter was unable to reach the occlusion, the physicians decided to remove the ace 64 and go back in with a new ace 64.However, after removing the ace 64 from the patient, the physicians noticed that the ica was dissected in the loop and they were unable to get back up to the ica.An angiogram was performed to confirm cross filling and the procedure was stopped.It is unknown exactly when the dissection occurred because there were no interim angiograms performed while the physicians were attempting to track the ace 64.However, the second physician indicated that the ica may have been dissected about 15-20 minutes before they recognized it.The patient has not suffered any further neurological deficits following the procedure.As of (b)(6) 2016, the patient has been discharged to rehab and is doing well.

• Brand Name: PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5381627
• Report Number: 3005168196-2016-00076
• Device Sequence Number: 55995
• Product Code: NRY
• UDI-Device Identifier: 00814548016207
• UDI-Public: 00814548016207
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K152541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Report Date (Section B): 12/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 06/28/2018
• Device Catalogue Number: 5MAXACE064-A
• Device Lot Number: F64632
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/20/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Other
• Patient Age: 60 YR