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

Catalog Number 5MAXACE064-A

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 05/26/2016

Event Type  malfunction  

Manufacturer Narrative

Results: the penumbra system ace 64 reperfusion catheter (ace 64) was fractured approximately 1.0 cm from the hub.Conclusions: evaluation of the returned device revealed the ace 64 was fractured.This type of damage typically occurs due to improper handling during preparation.If the ace 64 is manipulated forcefully at extreme angles during removal from the packaging hoop or preparation for use, damage such as this may occur.Ace 64 devices are 100% visually inspected during in-process inspection.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 64 reperfusion catheter (ace 64) was leaking saline at the junction of the hub and the catheter.There was no observed damage to the ace 64.However, due to the observed leak, the ace 64 was not used for the procedure.The procedure was completed using a new ace 64.

• Brand Name: PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 5749089
• MDR Text Key: 48154743
• Report Number: 3005168196-2016-00876
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548016207
• UDI-Public: 00814548016207
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152541
• 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: 05/27/2016

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: 06/10/2018
• Device Catalogue Number: 5MAXACE064-A
• Device Lot Number: F64356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/27/2016
• Initial Date FDA Received: 06/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2015
• 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