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

Model Number 80617

Device Problems Difficult to Remove (1528); Difficult to Advance (2920); Difficult to Open or Remove Packaging Material (2922); Material Integrity Problem (2978)

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

Event Date 11/08/2021

Event Type  malfunction  

Event Description

It was reported possible detached coating occurred.A 130cm x 20cm renegade stc 18 microcatheter was selected for use in an interventional procedure in the gastroduodenal artery (gda).During preparation, the carrier hoop of the renegade catheter was flushed well.The fathom guidewire was inserted and the torque device was connected.Resistance was felt during removal from the hoop.The physician advanced the renegade into a 5f 0.038 non-boston scientific guide catheter and strong resistance occurred after some centimeters.Although the fathom guidewire had advanced into the gda well, the renegade could not follow due to the resistance.The renegade was withdrawn with some resistance.Outside the patient, part of the outer coating was noticed to be disrupted over 2 cm.The procedure was completed with a different device.There were no patient complications.

Manufacturer Narrative

Device eval by mfr: the returned product consisted of a stc-18 microcatheter.The catheter was already removed from the shipping tube when received.The hub, shaft and tip were microscopically examined.The device showed 1 kink located 23.5cm.The device was microscopically inspected for any coating issues.No issues were noticed.A.016 guidewire was inserted into the lumen of the device.The renegade stc was inserted into a test.038 terumo angiographic catheter.The stc transcended through the lumen of the test catheter with no hesitations or restrictions.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.

Event Description

It was reported coating damage occurred.An stc 18 130cm x 20cm renegade was selected for use in an unknown procedure.During removing the renegade catheter from the carrier hoop, after flushing, inserting a fathom guidewire, and connecting a torque device, resistance was felt.The physician then advanced the renegade into a 5f 0.038 non-bsc guide catheter when strong resistance occurred after some centimeters.Although the fathom was advanced into the gastroduodenal artery (gda) well, the renegade could not follow because of the resistance.The renegade was removed with some resistance as well, and a small part of the outer coating was noticed to be disrupted over 2 cm.The procedure was completed with a different device with no patient complications.

• 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 CORPORATION; model farm road; cork IRELA ND; EI IRELAND
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12851141
• MDR Text Key: 281078357
• Report Number: 2134265-2021-14453
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 08714729444442
• UDI-Public: 08714729444442
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K023681
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• 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: 0027739692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1