MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER; NRY

Catalog Number	5MAXACE132
Medical Device Problem Codes	Kinked (1339); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	09/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was disposed of by the hospital and is no longer available for return.Without the return of the device, the root cause of the problem cannot be determined.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the left m1 segment of the middle cerebral artery (mca) using penumbra system 5max ace reperfusion catheters (5max aces).During the procedure, the physician placed a non-penumbra catheter toward the left internal carotid artery (ica), then opened a 5max ace package.However, the physician found that the proximal shaft of the 5max ace was kinked upon removing the 5max ace from the packaging hoop.Therefore, the 5max ace was set aside and the procedure was completed using a new 5max ace.There was no adverse effect to the patient.
Additional Manufacturer Narrative
The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Additional Manufacturer Narrative
The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
During preparation for a thrombectomy procedure using penumbra system 5max ace reperfusion catheters (5max aces), the physician noticed a kink on the proximal shaft of the 5max ace upon removal from the packaging hoop.Therefore, the 5max ace was set aside and did not come into contact with the patient.The procedure was completed using a new 5max ace.

• Brand Name: PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6918343
• Report Number: 3005168196-2017-01736
• Device Sequence Number: 1354474
• Product Code: NRY
• UDI-Device Identifier: 00814548012803
• UDI-Public: 00814548012803
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/13/2017

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: Physician
• Device Expiration Date: 05/21/2020
• Device Catalogue Number: 5MAXACE132
• Device Lot Number: F77245
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/13/2017
• Supplement Date Received by Manufacturer: 09/13/2017; 09/13/2017
• Initial Report FDA Received Date: 10/05/2017
• Supplement Report FDA Received Date: 10/06/2017; 10/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 89 YR