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

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/11/2019

Event Type  Injury  

Manufacturer Narrative

Please note that this complaint was submitted to the fda by the user facility with the following reference number: mw5091075.The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.

Event Description

The patient was undergoing a thrombectomy procedure in the posterior tibial artery using an indigo system catrx aspiration catheter (catrx), a non-penumbra sheath, a non-penumbra diagnostic catheter, and a guidewire.It was noted that the patient had arteriomegaly and a tortuous anatomy.During the procedure, the catrx was introduced into the target vessel and attempted to aspirate some of the thrombus.However, the catrx reached its maximum limitations in the distal calf and was unable to reach the remaining thrombus near the ankle and foot.Therefore, the physician decided to remove the catrx.Upon removal, the catrx broke and a long segment of the catheter remained in the patient's vessel.It was reported that the broken segment of catheter extended from the patient's iliac artery to just below the knee.Despite numerous attempts to snare the broken segment of catrx, it was unable to be removed.Additional attempts were made to retrieve the broken catrx using a non-penumbra balloon catheter and a new non-penumbra 6f heath.These attempts were also unsuccessful and the catrx was unable to be retrieved.The procedure was then ended.The following day the patient underwent a vessel take-down surgery to remove the remaining catrx.The surgery to remove the catrx was successful.However, the family decided not to pursue additional treatment for the initial thrombolytic condition, and the patient was transferred to comfort care.On (b)(6) 2019, the family decided to withdraw care from the patient and the patient expired.

• Brand Name: INDIGO SYSTEM CATRX ASPIRATION CATHETER
• Type of Device: QEX
• 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: 9446639
• MDR Text Key: 170139603
• Report Number: 3005168196-2019-02244
• Device Sequence Number: 1
• Product Code: QEX
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K163618
• 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: 01/01/2005,11/11/2019

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
• Was Device Available for Evaluation?: No
• 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: 11/11/2019
• Initial Date FDA Received: 12/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 93 YR