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

Catalog Number	5MAXACE064
Medical Device Problem Codes	Fracture (1260); Stretched (1601)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/28/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using a penumbra system ace 64 reperfusion catheter (ace 64).During the procedure, while retracting the ace 64 from the patient's torturous anatomy, the ace 64 became stretched and fractured.The distal part of the ace was removed from the patient using a snare device and the procedure was completed using a new ace 64.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The penumbra system ace 64 reperfusion catheter (ace 64) used to complete the procedure was also returned.Results: the first ace 64 was fractured approximately 124.0 cm from the hub, and stretched and ovalized approximately 104.0 cm from the hub.The second ace 64 was bent approximately 33.0, 88.0, and 114.0 cm from the hub.Conclusions: evaluation of the first ace 64 revealed it was fractured, stretched, and ovalized.This type of damage typically occurs due to forceful retraction of the ace 64 against resistance.The tortuous anatomy mentioned in the complaint may have contributed to any resistance experienced during retraction of the ace 64.Evaluation of the second ace 64 revealed it was kinked.This damage was likely incidental and may have occurred after successful completion of the procedure.Ace 64 devices 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 REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5635594
• Report Number: 3005168196-2016-00614
• Device Sequence Number: 23192
• Product Code: NRY
• UDI-Device Identifier: 00814548013961
• UDI-Public: 00814548013961
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K152541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Nurse
• Device Expiration Date: 08/12/2018
• Device Catalogue Number: 5MAXACE064
• Device Lot Number: F65266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/06/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/05/2016
• Supplement Report FDA Received Date: 06/10/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR