MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CATRX ASPIRATION CATHETER; QEX,QEW

Catalog Number CATRXKIT

Device Problems Break (1069); Material Deformation (2976); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/18/2022

Event Type  malfunction  

Event Description

The patient was undergoing a thrombectomy procedure in the superficial femoral artery (sfa), anterior tibial (at) artery and posterior tibial (pt) artery using an indigo system aspiration catheter 7 (cat7), an indigo system catrx aspiration catheter (catrx), and a non-penumbra sheath.It was reported that the patient¿s anatomy was moderately tortuous and the patient had a stent placed in the target vessel.During the procedure, the physician successfully completed two passes in the target vessel using the cat7.While torqueing the cat7 during the next pass; the physician experienced resistance.Therefore, the cat7 was removed from the sheath.Upon removal, the physician noticed that the cat7 was twisted and broken at the distal end, but it was connected.Subsequently, the physician decided to use a catrx and completed one pass.During the next pass, the physician encountered resistance and the catrx would not cross due to already placed stent.Therefore, the catrx was removed.Upon removal, the distal end of the catrx was noticed to be damaged.The procedure was completed using a new catrx.There was no report of an adverse effect to the patient.

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Manufacturer Narrative

Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #01 mfr report: 1.Section b.Box 5.Describe event or problem 2.Section d.Box 1.Brand name 3.Section d.Box 4.Lot # 4.Section d.Box 4.Catalog # 5.Section d.Box 4.Expiration date 6.Section d.Box 4.Unique identifier 7.Section d.Box 5.510(k) # evaluation of the returned catrx confirmed fracture on its proximal shaft.This is likely the reported distal fracture.Evaluation also revealed a kink and damaged distal tip.If the device is advanced against resistance during use, damage such as this may occur.Based on the reported event, the resistance was likely due to already placed stent.Further evaluation of the device revealed a kink on the proximal end of the guidewire lumen.This damage was likely incidental to the 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.H3 other text : placeholder.

Event Description

The patient was undergoing a thrombectomy procedure in the superficial femoral artery (sfa), anterior tibial (at) artery and posterior tibial (pt) artery using an indigo system aspiration catheter 7 (cat7), an indigo system catrx aspiration catheter (catrx), and a non-penumbra sheath.It was reported that the patient¿s anatomy was moderately tortuous and the patient had a stent placed in the target vessel.During the procedure, the physician successfully completed two passes in the target vessel using the cat7.While torqueing the cat7 during the next pass; the physician experienced resistance.Therefore, the cat7 was removed from the sheath.Subsequently, the physician decided to use a catrx and completed one pass.During the next pass, the physician encountered resistance and the catrx would not cross due to already placed stent.Therefore, the catrx was removed.Upon removal, the distal end of the catrx was noticed to be fractured.The procedure was completed using a new catrx.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM CATRX ASPIRATION CATHETER
• Type of Device: QEX,QEW
• 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: 14682466
• MDR Text Key: 301987281
• Report Number: 3005168196-2022-00283
• Device Sequence Number: 1
• Product Code: QEX
• UDI-Device Identifier: 00814548017556
• UDI-Public: 814548017556
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163618
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,07/21/2022

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 Catalogue Number: CATRXKIT
• Device Lot Number: F110082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/19/2022
• Initial Date FDA Received: 06/13/2022
• Supplement Dates Manufacturer Received: 07/11/2022
• Supplement Dates FDA Received: 07/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/23/2021
• 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: 77 YR
• Patient Sex: Male