MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 8; DXE

Model Number CAT8XTORQ115KIT-B

Device Problems Material Puncture/Hole (1504); Material Twisted/Bent (2981)

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

Event Date 10/21/2020

Event Type  malfunction  

Manufacturer Narrative

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 femoral popliteal artery using an indigo system aspiration catheter 8 (cat8), a penumbra engine (engine), a guidewire and non-penumbra sheath.It was noted that there was stenosis in the target vessel.During the procedure, the physician advanced the cat8 over the guidewire, through the sheath and into the target vessel to perform aspiration.Towards the end of the procedure, after completing three passes using the cat8, the physician noticed full aspiration could not be achieved with the engine.Upon examining the cat8, the physician observed that the proximal end of the cat8 was twisted and had a small hole where it was being torqued.Therefore, the cat8 was removed.The procedure was completed using an indigo system aspiration catheter 6 (cat6) and the same sheath.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 8
• 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: 10839933
• MDR Text Key: 216383447
• Report Number: 3005168196-2020-01992
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00815948022485
• UDI-Public: 00815948022485
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K160533
• 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: 01/01/2005,10/21/2020

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: 07/15/2023
• Device Model Number: CAT8XTORQ115KIT-B
• Device Catalogue Number: CAT8XTORQ115KIT
• Device Lot Number: H10624
• 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: 10/21/2020
• Initial Date FDA Received: 11/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2020
• 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: 52 YR
• Patient Weight: 127