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

Model Number CATRXKIT

Device Problems Material Puncture/Hole (1504); Suction Failure (4039)

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

Event Date 11/04/2020

Event Type  malfunction  

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) and a guidewire (.014).During the procedure, the physician completed two passes using the catrx.While attempting to make another pass, the physician advanced the catrx over the guidewire and into the target vessel, then initiated the aspiration.The physician then felt like the catrx did not have any aspiration and noticed the catrx lumen was punctured by the guidewire.Therefore, the catrx was removed.The procedure was completed using a new catrx.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the catrx had minor bends along its length.The non-penumbra guidewire was inside the catrx guidewire lumen.The non-penumbra guidewire was undamaged and was removed from the guidewire lumen without an issue.Conclusions: evaluation of the returned catrx confirmed that the guidewire lumen was punctured by the non-penumbra guidewire.If the guidewire is advanced into the guidewire lumen at an extreme angle, damage such as this may occur.Further evaluation revealed that during the functional test, the catrx was able to aspirate liquid without an issue; therefore, the reported inability to aspirate could not be confirmed.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.

Manufacturer Narrative

Please note that the following section was incorrectly reported on follow-up #01 mfr report and is being corrected on this follow-up #02 mfr report.1.Section h.10.Additional narrative and/or corrected data.Results: the catrx had minor bends along its length.The non-penumbra guidewire had punctured and was protruding from the catrx guidewire lumen.The non-penumbra guidewire was undamaged and was removed from the guidewire lumen without an issue.Conclusions: evaluation of the returned catrx confirmed that the guidewire lumen was punctured by the non-penumbra guidewire.If the guidewire is advanced into the guidewire lumen at an extreme angle, damage such as this may occur.Further evaluation revealed that during the functional test, the catrx was able to aspirate liquid without an issue; therefore, the reported inability to aspirate could not be confirmed.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 CATRX ASPIRATION CATHETER
• Type of Device: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10945675
• MDR Text Key: 219510063
• Report Number: 3005168196-2020-02171
• 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,Followup
• Report Date: 01/01/2005,11/06/2020

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: 04/06/2023
• Device Model Number: CATRXKIT
• Device Catalogue Number: CATRXKIT
• Device Lot Number: F97210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• 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: 11/06/2020
• Initial Date FDA Received: 12/04/2020
• Supplement Dates Manufacturer Received: 12/10/2020; 01/14/2005
• Supplement Dates FDA Received: 01/08/2021; 04/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 115