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

Model Number CATRXKIT

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

Patient Problem Death (1802)

Event Date 06/05/2020

Event Type  Death  

Manufacturer Narrative

Potential adverse events in the labeling with the indigo aspiration system include, but are not limited to, device malfunction, hematoma or hemorrhage at the site, inability to completely remove thrombus, peripheral thromboembolic events, emergent surgery, including death.Therefore, it was determined that the reported adverse events were anticipated complications.The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Event Description

The patient was undergoing a thrombectomy procedure in the right anterior tibial artery using an indigo system catrx aspiration catheter (catrx) and non-penumbra sheath (cook).During the procedure, the physician made a pass using the catrx and non-penumbra sheath.While attempting to remove the catrx for flushing, the catrx broke into two pieces and approximately 40 centimeters of the catrx distal end was left inside the patient.It was reported that the physician experienced resistance while removing the catrx after it had broken in two pieces.The physician then attempted to remove the broken distal end of the catrx using a snare device for approximately 60 minutes, but it was unsuccessful.The sheath was then removed and replaced with another non-penumbra sheath to complete the balloon angioplasty.Afterwards, the patient was sent to an intensive care unit with a femoral compression device placed on the left leg; however, the femoral compression device ended up clogging the patient¿s entire left leg.The following day, the surgeon performed a surgical intervention of the right leg to remove the broken piece of the catrx.Subsequently, the patient expired; however, the cause of death is unknown at this time.Furthermore, the relationship between the broken distal end of the catrx and death is unknown.

• Brand Name: INDIGO SYSTEM CAT RX ASPIRATION CATHETER
• Type of Device: DXE
• 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: 10204009
• MDR Text Key: 196730573
• Report Number: 3005168196-2020-00827
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548017556
• UDI-Public: 00814548017556
• 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: 01/01/2005,06/05/2020

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: 01/13/2023
• Device Model Number: CATRXKIT
• Device Catalogue Number: CATRXKIT
• Device Lot Number: F95547
• 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: 06/05/2020
• Initial Date FDA Received: 06/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 86 YR