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

Catalog Number 5MAXACE064-A

Device Problems Unraveled Material (1664); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/27/2016

Event Type  malfunction  

Manufacturer Narrative

Results: the penumbra system ace 64 reperfusion catheter (ace 64) was kinked in multiple locations; the distal tip of the ace 60 was inside the hub of the ace 64.Conclusions: evaluation of the returned devices confirmed that the ace 60 was fractured.This type of damage likely occurs due to improper handling during use.If the device is forcefully retracted against resistance, damage such as this may occur.In addition, the ace 60 was kinked in multiple locations.These kinks were likely incidental and may have occurred during packaging of the device for return.Further evaluation revealed that the ace 64 had unwound coil inside the hub.The unwound coil was revealed to be the distal tip of the fractured ace 60.This damage likely occurred due to attempts to insert the ace 60 through the ace 64.By design, the ace 60 is not compatible to be inserted through an ace 64, and attempts to use the devices in this manner will likely result in damage to one or both of the devices.The ace 64 was also kinked in multiple locations along the catheter¿s shaft.These kinks were incidental and may have occurred during packaging of the device for return.All 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.This report is associated with mfr report numbers: 3005168196-2016-00896.

Event Description

The patient was undergoing a thrombectomy procedure using a penumbra system ace 60 reperfusion catheter (ace 60) and a penumbra system ace 64 reperfusion catheter (ace 64).During the procedure, the physician used the ace 60 for the first pass and after aspiration, the ace 60 was removed.After removal, the tip of the ace 60 was found to be fractured and could not be used for the second pass.The physician did not encounter any resistance, friction or difficulty while using the ace 60.An ace 64 was then opened for the procedure and it was noticed that there was an unwinding of coiled wire at the hub of the ace 64.The physician attempted to advance a penumbra system 3max reperfusion catheter (3max) through the ace 64; however, the wire was uncoiling again at the hub and subsequently, the ace 64 did not enter the patient's body.Again, the physician did not encounter any resistance or friction while attempting to advance the 3max through the ace 64.The procedure was then successfully completed using a new ace 64 and the same 3max.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 5749356
• MDR Text Key: 48191860
• Report Number: 3005168196-2016-00897
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548016207
• UDI-Public: 00814548016207
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/08/2018
• Device Catalogue Number: 5MAXACE064-A
• Device Lot Number: F65618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 64 YR