MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 6; DXE

Model Number CAT6KIT-A

Device Problems Material Deformation (2976); Physical Resistance/Sticking (4012); Suction Failure (4039)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/26/2021

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 anterior tibial artery using an indigo system aspiration catheter 6 (cat6), indigo system separator 6 (sep6), and non-penumbra sheath.During the procedure, the cat6 was inserted into the sheath and advanced to the target location with the peel away sheath.It was reported that slight resistance was experienced.Subsequently, the physician began to aspirate but was not getting blood return.The physician then inserted the sep6 into the cat6, but the sep6 would not exit the distal end of the cat6.Therefore, the cat6 and sep6 were removed, and the physician found the distal end of the cat6 was kinked.The procedure was completed by using an indigo system catrx aspiration catheter (catrx) and the same sheath.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 6
• 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: 11576599
• MDR Text Key: 243005167
• Report Number: 3005168196-2021-00598
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00815948020405
• UDI-Public: 00815948020405
• 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: 01/01/2005,02/26/2021

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: 11/12/2023
• Device Model Number: CAT6KIT-A
• Device Catalogue Number: CAT6KIT
• Device Lot Number: F101927
• 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: 02/26/2021
• Initial Date FDA Received: 03/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2020
• 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: 66 YR