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

Catalog Number 5MAXACE068KIT

Device Problems Break (1069); Material Separation (1562); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 01/29/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Results: the penumbra system ace 68 reperfusion catheter (ace 68) was fractured approximately 112.0 cm from the hub.Conclusions: evaluation of the returned device confirmed that the ace 68 was fractured.This type of damage typically occurs due to improper handling during removal from the packaging.If the ace 68 is withdrawn from its packaging shell at extreme angles before removing the tubing tray, damage such as this may occur.Penumbra catheters are visually inspected during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 penumbra system ace 68 reperfusion catheter (ace 68) snapped and broke around the distal end while the radiologic technologist was removing the ace 68 from its packaging shell.The ace 68 broke prior to use and therefore, was not used in the procedure.The procedure was completed using a new penumbra system ace 68 hi-flow kit (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: 6366850
• MDR Text Key: 68604219
• Report Number: 3005168196-2017-00268
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Expiration Date: 11/08/2019
• Device Catalogue Number: 5MAXACE068KIT
• Device Lot Number: F72687
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2016
• 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