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

Catalog Number	5MAXACE064
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/31/2016
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.This report is associated with mfr report numbers: 3005168196-2016-00600.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using a penumbra system 3max reperfusion catheter (3max) and a penumbra system ace 64 reperfusion catheter (ace 64).During the procedure, while using the 3max and ace 64, the physician experienced no unusual resistance; however, the 3max and ace 64 became kinked and were removed.The procedure was completed using a new 3max and a new ace 64.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the penumbra system ace 64 reperfusion catheter (ace 64) was kinked approximately 20.5 cm from the hub.Conclusions: evaluation of the returned devices confirmed that the penumbra system 3max reperfusion catheter (3max) and ace 64 were kinked.This type of damage typically occurs due to improper handling during use.If the devices are forcefully advanced or manipulated at an angle during insertion or positioning, damage such as a kink may occur.Further evaluation revealed the 3max was ovalized in the distal shaft.This damage may have occurred due to forceful gripping or pinching of the 3max during insertion into the patient.Further evaluation of the returned devices revealed that the tubing was functional.The tubing was connected to an aspiration pump and aspiration was present.3maxs and ace64s 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: 5624835
• Report Number: 3005168196-2016-00601
• Device Sequence Number: 18968594
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2016

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: 05/25/2018
• Device Catalogue Number: 5MAXACE064
• Device Lot Number: F64078
• 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: 04/05/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/03/2016
• Supplement Report FDA Received Date: 06/01/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR