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

Catalog Number	5MAXACE064KIT-A
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/07/2016
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 in the right m1 segment of the middle cerebral artery (mca) using a penumbra system ace 64 kit (kit).During the procedure, the physician inserted the penumbra system ace 64 reperfusion catheter (ace 64) through another manufacturer's sheath and then advanced the ace 64 to the face of the clot.Next, the penumbra hi-flow aspiration tubing (tubing) was connected and aspiration was initiated.As the physician pulled the ace 64 back from the clot, the hub separated from the ace 64.The physician immediately turned off the aspiration, disconnected the tubing and removed the ace 64 from the patient.Another kit was opened and a new ace 64 was introduced to the face of the clot.The same tubing was connected and aspiration was restarted.As the physician began to aspirate, he had trouble applying enough force on the tubing to get it to stay on.After much effort, the physician was able to get the flow switch completely to the "on" position.The procedure was completed without further issues and the clot was removed using solumbra technique.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Result: the penumbra system ace 64 reperfusion catheter (ace64) strain relief was kinked approximately 1.2 cm from the hub.The ace64 was fractured underneath the strain relief.The coil wire of the catheter shaft was partially unraveled, which caused the shaft to fall out of the ace64 strain relief.Conclusion: evaluation of the returned device revealed that the ace64 was kinked and fractured under the strain relief.This type of damage typically occurs due to improper handling during use.If the ace64 is forcefully manipulated at extreme angles during use, 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 REPERFUSION CATHETER KIT
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5704614
• Report Number: 3005168196-2016-00759
• Device Sequence Number: 10890266
• Product Code: NRY
• UDI-Device Identifier: 00814548016481
• UDI-Public: 00814548016481
• Combination Product (Y/N): N
• 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): 05/09/2016

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: 10/07/2018
• Device Catalogue Number: 5MAXACE064KIT-A
• Device Lot Number: F65979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/09/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/07/2016
• 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