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 12/26/2016

Event Type  malfunction  

Manufacturer Narrative

(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 penumbra system ace 68 reperfusion catheter broke into two pieces in the middle of the catheter upon removal from the packaging.The damage to the ace 68 occurred prior to use and therefore, it was not used in the procedure.The procedure was continued using a penumbra system ace 60 reperfusion catheter (ace 60).

Manufacturer Narrative

Please note that the device is no longer available for return as mentioned in the initial mdr; therefore, the mdr was updated accordingly.The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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: 6274712
• MDR Text Key: 65672884
• Report Number: 3005168196-2017-00111
• 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,Followup
• Report Date: 12/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/08/2019
• Device Catalogue Number: 5MAXACE068KIT
• Device Lot Number: F72687
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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