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

Catalog Number	5MAXACE064KIT-A
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/09/2016
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
The patient was undergoing a thrombectomy procedure using a penumbra system ace 64 reperfusion catheter (ace 64).During the procedure, the physician advanced other manufacturer's devices and the ace 64 into the patient and attempted to inject saline through the ace 64.However, while injecting saline, the proximal portion of the ace 64 became unraveled.The ace 64 and the other manufacturer's devices were removed from the patient and the procedure was completed using a new ace 64 and other manufacturers'' devices.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 fractured approximately 11.0 cm from the hub and kinked in multiple locations throughout its length.The ace 64 was returned with a non-penumbra microcatheter inserted through it, with a non-penumbra stent inside the microcatheter.Conclusions: evaluation of the returned devices revealed the ace 64 was fractured and kinked.This damage typically occurs due to improper handling of the ace 64 during use.If the ace 64 is forcefully manipulated against resistance, damage such as this may occur.If saline is injected through an already fractured ace 64, the catheter shaft may further unravel due to the distal segment being pushed away from the proximal segment by saline.Penumbra catheters are 100% visually evaluated during in-process inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Additional Manufacturer Narrative
Correction to section device manufacturer date: 9/23/2015.

• Brand Name: PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER KIT
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5563247
• Report Number: 3005168196-2016-00460
• Device Sequence Number: 494771
• Product Code: NRY
• UDI-Device Identifier: 00814548016481
• UDI-Public: 00814548016481
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/10/2016

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: Physician
• Device Expiration Date: 09/22/2018
• Device Catalogue Number: 5MAXACE064KIT-A
• Device Lot Number: F65811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/10/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/08/2016
• Supplement Report FDA Received Date: 05/13/2016; 06/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1