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

Catalog Number 5MAXACE068KIT

Device Problems Break (1069); Material Separation (1562); Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Date 03/17/2017

Event Type  malfunction  

Manufacturer Narrative

Please note that the following device codes also apply to this complaint: (b)(4).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 hospital staff noticed that the penumbra system ace 68 reperfusion catheter (ace 68) was coming apart upon removal from the packaging of the penumbra system ace 68 hi-flow kit (kit).The damaged ace 68 was noticed prior to use and therefore, was not used in the procedure.The procedure was completed using a new kit.

Manufacturer Narrative

Results: the penumbra system ace 68 reperfuslion catheter (ace 68) was fractured approximately 63.0 cm from the hub and ovalized on the distal tip.Conclusions: evaluation of the returned device revealed that it was fractured.This type of damage typically occurs if the ace 68 is withdrawn from the packaging tray prior to removing the tubing tray.Further evaluation revealed the ace 68 was ovalized on its distal tip.This damage was likely incidental and may have occurred during packaging for return.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: 6490604
• MDR Text Key: 72796920
• Report Number: 3005168196-2017-00591
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548016603
• UDI-Public: 00814548016603
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K161640
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/03/2019
• Device Catalogue Number: 5MAXACE068KIT
• Device Lot Number: F72634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2016
• 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