MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE 64 HI-FLOW KIT; NRY

Catalog Number 5MAXACE064KIT

Device Problems Stretched (1601); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Date 09/30/2017

Event Type  malfunction  

Manufacturer Narrative

The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

During preparation for a thrombectomy procedure, the hospital technician opened the packaging of the penumbra system ace 64 hi-flow kit (kit) and then the physician removed the penumbra system ace 64 reperfusion catheter (ace64) from the packaging.Upon removal from the packaging, the physician noticed that the ace64 was stretched at the mid shaft and that the inner coil could be seen.The damaged ace64 was found prior to use and therefore, was not used for the procedure.The procedure was completed using a non-penumbra balloon catheter and stent retriever device.

Manufacturer Narrative

The penumbra system ace 64 reperfusion catheter (ace64) was fractured approximately 61.0 cm from the hub.Evaluation of the returned device revealed that the ace64 was fractured.This type of damage typically occurs if an attempt to withdraw the ace64 from the kit packaging is made prior to removing the tubing tray.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.

• Brand Name: PENUMBRA SYSTEM ACE 64 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: 7021184
• MDR Text Key: 92734489
• Report Number: 3005168196-2017-01966
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548016467
• UDI-Public: 00814548016467
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K160449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 10/13/2017

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
• Device Operator: Physician
• Device Expiration Date: 08/26/2019
• Device Catalogue Number: 5MAXACE064KIT
• Device Lot Number: F71307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2017
• Initial Date FDA Received: 11/10/2017
• Supplement Dates Manufacturer Received: 11/17/2017
• Supplement Dates FDA Received: 12/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2016
• 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