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); Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Date 12/06/2016

Event Type  malfunction  

Manufacturer Narrative

The penumbra system ace 68 reperfusion catheter (ace 68) was kinked approximately 71.0 cm from the hub.Evaluation of the returned device revealed it was kinked.This type of damage typically occurs if the ace 68 is withdrawn from the packaging shell prior to removing the tubing tray.Penumbra coils and catheters are inspected during in-process inspection and during quality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 physician noticed that the braiding at the end of a penumbra system ace 68 reperfusion catheter (ace 68) did not look ¿correct¿ upon removing it from the packaging.The ace 68 was noticed prior to use and therefore, it 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: 6226372
• MDR Text Key: 64019212
• Report Number: 3005168196-2017-00012
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548016597
• UDI-Public: 00814548016597
• 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: 12/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/06/2019
• Device Catalogue Number: 5MAXACE068KIT
• Device Lot Number: F72435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2016
• 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