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

Catalog Number 5MAXACE132

Device Problems Kinked (1339); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 09/12/2017

Event Type  malfunction  

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 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.

Manufacturer Narrative

The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Manufacturer Narrative

The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Event 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
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 6918343
• MDR Text Key: 89472071
• Report Number: 3005168196-2017-01736
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548012803
• UDI-Public: 00814548012803
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/21/2020
• Device Catalogue Number: 5MAXACE132
• Device Lot Number: F77245
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 89 YR