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

Catalog Number 5MAXACE068KIT

Device Problems Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311); Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Date 02/19/2017

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

During preparation for a thrombectomy procedure, the physician noticed that the penumbra system ace 68 reperfusion catheter (ace 68) was ripped upon removal from the packaging of the penumbra system ace 68 hi-flow kit (kit).The damaged ace 68 was found prior to use and therefore, was not used for the procedure.The procedure was completed using a new penumbra system ace 68 hi-flow kit.

Manufacturer Narrative

Results: the ace 68 was fractured approximately 58.0 cm from the hub.Conclusions: evaluation of the returned device revealed the ace 68 was fractured.This type of damage typically occurs if the tubing tray is not removed prior to withdrawing the ace 68 from the packaging shell.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 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: 6425808
• MDR Text Key: 70649738
• Report Number: 3005168196-2017-00432
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548016603
• UDI-Public: 00814548016603
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K161640
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/10/2019
• Device Catalogue Number: 5MAXACE068KIT
• Device Lot Number: F71997
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2016
• 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