MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER; NRY

Catalog Number 5MAXACE064-A

Device Problems Component Missing (2306); Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Date 11/11/2015

Event Type  malfunction  

Manufacturer Narrative

The device packaging is available for return.A follow up mdr will be submitted upon completion of the investigation.

Event Description

During preparation for a thrombectomy procedure, the lead technologist noticed that a penumbra system ace 64 reperfusion catheter (ace 64) was missing from its packaging.The procedure continued using a new ace 64.

Manufacturer Narrative

(b)(4).The device packaging is no longer available for evaluation.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.The product was missing from its package.

• Brand Name: PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER
• 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: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 5324793
• MDR Text Key: 34288424
• Report Number: 3005168196-2015-01330
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548016207
• UDI-Public: 00814548016207
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142458
• 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: 11/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/06/2018
• Device Catalogue Number: 5MAXACE064-A
• Device Lot Number: F64064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2015
• 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