MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RENEGADE STC 18; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 80617

Device Problem Material Integrity Problem (2978)

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

Event Date 05/10/2022

Event Type  malfunction  

Event Description

It was reported that the coating of renegade was fractured.The target lesion was located in the liver.A renegade stc 18 catheter-infusion was selected for use.During preparation, it was noted that the coating of renegade was fractured.The procedure was completed with another of same device.No patient complications were reported and patient was stable post procedure.

Event Description

It was reported that the coating of renegade was fractured.The target lesion was located in the liver.A renegade stc 18 catheter-infusion was selected for use.During preparation, it was noted that the coating of renegade was fractured.The procedure was completed with another of same device.No patient complications were reported and patient was stable post procedure.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.The device was inspected for any damage or irregularities.The renegade stc 18 was received in the shipping hoop.The hoop was hydrated, and the device was removed.No fractures or damage to the coating was visible to the eye or with the microscope.Tactile analysis could find no places where there was a problem with the coating.It was found to be slippery where it should be when hydrated.An in house guide wire was inserted and the renegade stc 18 was advanced through an in house terumo guide catheter without resistance.No other issues were identified during the product analysis.The reported issue was not confirmed.

• Brand Name: RENEGADE STC 18
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14592571
• MDR Text Key: 293282115
• Report Number: 2134265-2022-06016
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 08714729444442
• UDI-Public: 08714729444442
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K023681
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 80617
• Device Catalogue Number: 80617
• Device Lot Number: 0027895079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2021
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 75 KG