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

Catalog Number 5MAXACE068KIT

Device Problems Fracture (1260); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Date 11/29/2017

Event Type  malfunction  

Manufacturer Narrative

Results: the ace68 was kinked 57.5 cm from the hub.There were no visible fractures on the ace68.Conclusions: evaluation of the returned ace68 revealed a single kink along the mid-shaft of the catheter.If the catheter is retracted from the kit packaging prior to removing the top tray the catheter it may become pinned between the trays and kink.There were no visible fractures on the ace68.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 a penumbra system ace 68 reperfusion catheter (ace68) was fractured mid shaft upon removal from the packaging.The damage to the ace68 was found prior to use, and therefore the ace68 was not used in the procedure.The procedure was completed using a new ace68.

• Brand Name: PENUMBRA SYSTEM ACE 68 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: 7148411
• MDR Text Key: 95931076
• Report Number: 3005168196-2017-02298
• 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: Physician
• Type of Report: Initial
• Report Date: 11/29/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 10/21/2019
• Device Catalogue Number: 5MAXACE068KIT
• Device Lot Number: F72388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2017
• Initial Date FDA Received: 12/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2016
• 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