MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE 68 HI-FLOW KIT; NRY

Catalog Number 5MAXACE068KIT

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

Patient Problem No Patient Involvement (2645)

Event Date 10/03/2017

Event Type  malfunction  

Manufacturer Narrative

The penumbra system ace 68 reperfusion catheter (ace68) was fractured approximately 3.0 cm from the hub at the end of the strain relief.Evaluation of the returned ace68 revealed a fracture in the proximal shaft.This damage was likely a result of attempting to remove the device from its packaging before first removing the top packaging tray.This would require the device to be positioned at extreme angles and may have contributed to the fracture.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.

Event Description

During preparation for a thrombectomy procedure, the hospital staff noticed that the penumbra system ace 68 reperfusion catheter (ace68) was kinked upon inspection before removal from the packaging of the penumbra system ace 68 hi-flow kit (kit).It was reported that the device packaging box was not bent.The damaged ace68 was found prior to use and therefore, was not used in the procedure.The procedure was completed using a new kit.

• Brand Name: PENUMBRA SYSTEM ACE 68 HI-FLOW KIT
• 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: 7031393
• MDR Text Key: 92481922
• Report Number: 3005168196-2017-01978
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548016603
• UDI-Public: 00814548016603
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161640
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2020
• Device Catalogue Number: 5MAXACE068KIT
• Device Lot Number: F75086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2017
• 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