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

Catalog Number CATRXKIT

Device Problems Device Damaged Prior to Use (2284); Arcing of Electrodes (2289); Device Handling Problem (3265)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/08/2018

Event Type  malfunction  

Manufacturer Narrative

Results: the cat rx was kinked approximately 124.0 cm from the hub, approximately 18.0 cm from the distal tip.The cat rx side lumen was punctured approximately 138.0 cm from the hub, approximately 4.0 cm from the distal tip.The cat rx was damaged and, therefore, non-functional.Conclusions: evaluation of the returned cat rx revealed the side lumen was fractured near the distal tip.If the guidewire is manipulated at extreme angles when being introduced to the side lumen, damage such as this may occur.This puncture may have resulted in resistance while attempting to advance the cat rx into the guide catheter.Further evaluation revealed the cat rx was kink approximately 12.0 cm proximal to the side lumen puncture.If the cat rx was continually advanced against the resistance created by the punctured side lumen, the catheter may become kinked.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

During preparation for a thrombectomy procedure, the physician found that the an indigo system cat rx aspiration catheter (catrx) was kinked during set up.The damage to the catrx was found prior to use and therefore, the catrx was not used in the procedure.The procedure was completed using a new catrx.

• Brand Name: INDIGO SYSTEM CAT RX 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: 7748387
• MDR Text Key: 116095600
• Report Number: 3005168196-2018-01513
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548017556
• UDI-Public: 00814548017556
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K163618
• 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: 01/01/2005,07/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2021
• Device Catalogue Number: CATRXKIT
• Device Lot Number: F81461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 07/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2018
• 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