MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 6; DXE

Catalog Number CAT6

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/29/2019

Event Type  malfunction  

Manufacturer Narrative

During decontamination, the bleach solution was flushed through the returned indigo system aspiration catheter 6 (cat6) and liquid was observed exiting the device near the hub; therefore, the strain relief was unwound.The cat6 was fractured beneath the strain relief approximately 1.0 cm from the hub.The device was kinked approximately 14.5, 36.0, 56.5, 82.5, 106.0 and 109.0 cm from the hub.Conclusions: evaluation of the returned cat6 revealed a fracture near the hub beneath the strain relief.If the cat6 is forcefully manipulated at extreme angles or otherwise mishandled during removal from its packaging, the device may kink and subsequently fracture.During functional testing, the cat6 was flushed with air while submerged and air leaked from the catheter at the fractured location.Further evaluation revealed bends and kinks along the length of the device.These damages were likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.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 in the right superficial femoral artery (sfa) using an indigo system aspiration catheter 6 (cat6) and an indigo system catheter 3 (cat3).During the procedure, the physician advanced the cat6 over the guidewire approximately 2-3 cm into the non-penumbra sheath and reported that the section of braided wire near the proximal end of the cat6 was fractured and leaking blood.The cat6 was therefore removed and was no longer used in the procedure.The physician decided to use a cat3 to continue the procedure.However, the cat3 became blocked with clot during aspiration.The physician then removed and flushed the cat3 system before re-advancing back into the target vessel.This occurred approximately five times before the physician decided to discontinue use of the cat3.The procedure was then completed using other devices.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 6
• 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: 8961513
• MDR Text Key: 156484460
• Report Number: 3005168196-2019-01671
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548016245
• UDI-Public: 00814548016245
• Combination Product (y/n): Y
• 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: 01/01/2005,08/05/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2020
• Device Catalogue Number: CAT6
• Device Lot Number: F80268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2019
• 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
• Initial Date Manufacturer Received: 08/05/2019
• Initial Date FDA Received: 09/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2017
• 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: 93 YR