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

Catalog Number 5MAXACE068KIT

Device Problems Break (1069); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Date 12/28/2017

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 hospital staff found that the penumbra system ace 68 reperfusion catheter (ace68) was broken upon removal from the packaging.The damage to the ace68 was found prior to use, and therefore it was not used in the procedure.The procedure was completed using a new ace68.

Manufacturer Narrative

Results: the ace68 was fractured approximately 39.0 cm from the hub, ovalized approximately 110.0 and 130.0 cm from the hub, and kinked approximately 125.0 cm from the hub.Conclusions: evaluation of the returned device revealed the ace68 was kinked, ovalized, and fractured.This damage may have occurred due to forceful handling of the ace68 during removal from the packaging or preparation for use.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 (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7219055
• MDR Text Key: 98308687
• Report Number: 3005168196-2018-00203
• 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
• Type of Report: Initial,Followup
• Report Date: 12/28/2017

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: 10/18/2020
• Device Catalogue Number: 5MAXACE068KIT
• Device Lot Number: F80040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/28/2017
• Initial Date FDA Received: 01/25/2018
• Supplement Dates Manufacturer Received: 03/19/2018
• Supplement Dates FDA Received: 05/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2017
• 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