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 02/10/2018

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 medical procedure, the hospital staff noticed that the penumbra system ace 68 reperfusion catheter (ace68) was broken upon removal from the penumbra system ace 68 hi-flow kit (kit) packaging.The damage to the ace68 was found prior to use.Therefore the ace68 was not used in the procedure.The procedure was completed using a new ace68 kit.

Manufacturer Narrative

Please note 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.The hospital discarded the device.

• 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: 7333793
• MDR Text Key: 102211667
• Report Number: 3005168196-2018-00531
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548016603
• UDI-Public: 00814548016603
• Combination Product (y/n): Y
• Reporter Country Code: CA
• 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,Followup
• Report Date: 01/01/2005,02/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/04/2020
• Device Catalogue Number: 5MAXACE068KIT
• Device Lot Number: F80855
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 01/14/2005
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2017
• 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