MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT 3 ASPIRATION CATHETER; DXE

Catalog Number CAT3

Device Problems Break (1069); Retraction Problem (1536); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/18/2018

Event Type  malfunction  

Manufacturer Narrative

Results: the cat3 was fractured approximately 120.0 cm from the hub.The distal fractured segment of the cat3 was flattened and ovalized throughout its length.The cat3 was deformed along its length.Conclusions: evaluation of the returned cat3 revealed the device was fractured at its distal joint.The distal fractured segment was ovalized along its length indicating the device may have become pinned against anatomy or other devices at some point during the procedure.The fracture damage is likely a result of forcefully retracting against this resistance.Further evaluation revealed the cat3 was deformed along its length.This damage is likely a result of packaging for return to penumbra.No other devices associated with this complaint were returned for evaluation.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Event Description

The patient was undergoing a thrombectomy procedure using an indigo system cat3 aspiration catheter (cat3).During the procedure, the physician experienced resistance while advancing the cat3 through the sheath, and therefore the physician attempted to retract the cat3.Upon retraction, the cat3 broke about 20cm from the distal tip of the catheter.The physician was able to remove the distal piece of the cat3 by retracting the guidewire inside of the cat3.

• Brand Name: INDIGO SYSTEM CAT 3 ASPIRATION CATHETER
• Type of Device: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7334507
• MDR Text Key: 102345191
• Report Number: 3005168196-2018-00551
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548016085
• UDI-Public: 00814548016085
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160533
• 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: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/09/2020
• Device Catalogue Number: CAT3
• Device Lot Number: F79885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2017
• 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: 97