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

Catalog Number 5MAXACE068KIT

Device Problems Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311); Device Handling Problem (3265)

Patient Problem No Patient Involvement (2645)

Event Date 07/15/2017

Event Type  malfunction  

Manufacturer Narrative

Results: the penumbra system ace 68 reperfusion catheter (ace68) was ovalized approximately 97.0-117.0 cm distal from the hub.The ace68 was kinked approximately 131.0 from the distal tip.Conclusion: evaluation of the returned ace68 confirmed that the distal tip was kinked and there was ovalization along the catheter body.This type of damage can occur if the ace68 is forcefully retracted at extreme angles from its product 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.

Event Description

During preparation for a thrombectomy procedure, the hospital staff noticed that the tip of the penumbra system ace 68 reperfusion catheter (ace68) was pinched upon removal from the packaging of the penumbra system ace 68 kit (kit).The damaged ace68 was found prior to use and therefore, was not used in the procedure.The procedure was completed using a new kit.

• Brand Name: PENUMBRA SYSTEM ACE 68 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: 6769159
• MDR Text Key: 81958806
• Report Number: 3005168196-2017-01368
• 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: 07/17/2017

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: 02/21/2020
• Device Catalogue Number: 5MAXACE068KIT
• Device Lot Number: F74491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2017
• Initial Date FDA Received: 08/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2017
• 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