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

Model Number CATRXKIT

Device Problems Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation of Vessels (2135)

Event Date 01/02/2020

Event Type  Injury  

Manufacturer Narrative

The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a thrombectomy procedure in the left anterior descending artery (lad) using an indigo system catrx aspiration catheter (catrx), penumbra engine (engine) and, non-penumbra guide catheter.During the procedure, the physician was unable to advance the catrx with the aspiration turned on; therefore, the engine was turned off.The physician then advanced the catrx into the target vessel and turned the engine back on to aspirate from distal to the proximal end of the lad.The procedure was completed using the same catrx, engine and, guide catheter.It was reported that the physician noticed a dissection in the lower lad during the procedure when taking a few pictures.The dissection was treated using a stent.

Manufacturer Narrative

Please note that the following sections were incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report: 3005168196-2020-00098: 1.Section b.Box 1.Adverse event and/or product problem.2.Section h: box 6.Device code 1.Potential adverse events in the labeling with the indigo aspiration system include, but are not limited to, device malfunction, dissection, or perforation, vessel spasms, thrombosis, hematoma or hemorrhage at the site, inability to completely remove thrombus, ischemia, intimal disruption, including death.Therefore, it was determined that the reported adverse event was an anticipated complication.Results: bends were present along the proximal shaft and kinks were present approximately 20.5 and 30.0 cm from the hub.The distal tip was ovalized approximately 143.0 cm from the hub.Conclusions: evaluation of the returned catrx revealed an ovalization on the distal tip.This may have been a result of advancing against the resistance experienced during the procedure.The root cause of the resistance experienced could not be determined.Further evaluation revealed bends and kinks on the proximal shaft.These damages were likely incidental to the reported complaint.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.

• Brand Name: INDIGO SYSTEM CAT RX ASPIRATION CATHETER
• Type of Device: QEX
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9625568
• MDR Text Key: 176432716
• Report Number: 3005168196-2020-00098
• Device Sequence Number: 1
• Product Code: QEX
• UDI-Device Identifier: 00814548017556
• UDI-Public: 00814548017556
• Combination Product (y/n): Y
• PMA/PMN Number: K163618
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/04/2022
• Device Model Number: CATRXKIT
• Device Catalogue Number: CATRXKIT
• Device Lot Number: F92891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2020
• 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: 01/03/2020
• Initial Date FDA Received: 01/24/2020
• Supplement Dates Manufacturer Received: 04/07/2020
• Supplement Dates FDA Received: 04/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 67 YR