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

Catalog Number	5MAXACE064KIT-A
Medical Device Problem Codes	Fracture (1260); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
During preparation for a thrombectomy procedure, the physician noticed that the penumbra system ace 64 reperfusion catheter (ace 64) was fractured upon removal from its packaging.The fractured ace 64 was found prior to use and therefore, was not used for the procedure.The procedure was completed using a new ace 64.
Additional Manufacturer Narrative
Result: the penumbra system ace 64 reperfusion catheter (ace 64) was fractured approximately 105.0 cm from the hub.The ace 64 was ovalized approximately 33.5, 36.5, and 65.0 cm from the hub, and 15.5 cm from the distal tip.Conclusion: evaluation of the returned device revealed that the ace 64 was fractured on the distal shaft, and ovalized in multiple locations along the entire catheter shaft.This type of damage likely occurred due to improper handling of the catheter.If the device is forcefully manipulated during removal from the packaging, or during preparation for the procedure, damage such as this may occur.Penumbra catheters are 100% visually inspected during in-process inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: PENUMBRA SYSTEM ACE 64 KIT
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5788254
• Report Number: 3005168196-2016-00949
• Device Sequence Number: 16193077
• Product Code: NRY
• UDI-Device Identifier: 00814548016481
• UDI-Public: 00814548016481
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K152541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2016

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
• Operator of Device: Physician
• Device Expiration Date: 10/01/2018
• Device Catalogue Number: 5MAXACE064KIT-A
• Device Lot Number: F65906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/12/2016
• Supplement Report FDA Received Date: 08/17/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1