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

Catalog Number	5MAXACE064
Medical Device Problem Codes	Break (1069); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/02/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the penumbra system ace 64 reperfusion catheter (ace 64) was fractured approximately 91.0 cm from the hub; the ace64 was kinked approximately 25.0, 40.0, and 66.5 cm from the hub.Conclusions: evaluation of the returned device revealed that the ace64 was kinked in multiple locations along the catheter shaft, and fractured on the distal shaft.These types of damage typically occur due to improper handling during preparation.If the ace64 is manipulated at extreme angles with excessive force, these types of damage may occur.These devices are 100% visually inspected for damage during in-process inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
During preparation for a thrombectomy procedure, the hospital staff noticed that the shaft of the penumbra system ace 64 reperfusion catheter (ace 64) was damaged upon removal from its packaging.The damaged ace 64 was found prior to use and was not used for the procedure.The procedure was completed using a new ace 64.

• Brand Name: PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5420260
• Report Number: 3005168196-2016-00139
• Device Sequence Number: 567738
• Product Code: NRY
• UDI-Device Identifier: 00814548013961
• UDI-Public: 00814548013961
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K152541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/10/2016

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: Health Professional
• Device Expiration Date: 05/07/2018
• Device Catalogue Number: 5MAXACE064
• Device Lot Number: F63856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2016
• Initial Report FDA Received Date: 02/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1