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

Model Number CATRXKIT

Device Problems Break (1069); Failure to Advance (2524)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/18/2020

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2020-02267.

Event Description

The patient was undergoing a thrombectomy procedure in the left circumflex using indigo system catrx aspiration catheters (catrxs) and a 6fr guide catheter.During the procedure, the physician was unable to track two catrxs to the thrombus in the circumflex, but the catrxs did not have issues delivering a balloon.The catrxs broke before exiting the same guide catheter.A catrx broke at the mid-shaft, and the other catrx at the proximal end.It was reported that the break may have occurred due to the patient anatomy.Therefore, the catrxs were removed.The patient was treated with medication, percutaneous transluminal angioplasty (pta), and stenting.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the first catrx was fractured approximately 45.0 cm from the hub.The catrx was ovalized approximately 46.0 cm from the hub.Conclusions: evaluation of the first returned catrx confirmed a fractured catheter.If the catrx is forcefully advanced against resistance, damage such as a kink and subsequent fracture may occur.Evaluation of the second returned catrx confirmed a fractured catheter.If the catrx is forcefully advanced against resistance, damage such as a kink and subsequent fracture may occur.The root cause of the reported unable to track the two catrxs to the thrombus could not be determined.Penumbra catheters are visually 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.This report is associated with mfr report number: 3005168196-2020-02267.

• Brand Name: INDIGO SYSTEM CATRX ASPIRATION CATHETER
• Type of Device: QEX, QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10999076
• MDR Text Key: 222078585
• Report Number: 3005168196-2020-02266
• 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: 01/01/2005,11/18/2020

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: 03/06/2023
• Device Model Number: CATRXKIT
• Device Catalogue Number: CATRXKIT
• Device Lot Number: F96758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• 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: 11/18/2020
• Initial Date FDA Received: 12/13/2020
• Supplement Dates Manufacturer Received: 12/18/2020
• Supplement Dates FDA Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 88 YR