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

Model Number 29417

Device Problem Break (1069)

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

Event Date 09/21/2022

Event Type  malfunction  

Event Description

It was reported that the catheter was broken.A 105/3.0/2.5/.021/20/straight renegade microcatheter was selected for use in the liver.During the procedure, it was noted that the catheter was broken.The procedure was completed with another of the same device.No complications were reported and patient is good post procedure.

Event Description

It was reported that the catheter was broken.A 105/3.0/2.5/.021/20/straight renegade microcatheter was selected for use in the liver.During the procedure, it was noted that the catheter was broken.The procedure was completed with another of the same device.No complications were reported and patient is good post procedure.

Manufacturer Narrative

Device evaluated by mfr: the complaint device was received for product analysis.The hub and shaft were visually inspected when returned.The renegade device showed multiple small bends and kinks.The shaft showed stretching and a fracture located 33cm from the hub.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.

• Brand Name: RENEGADE
• 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: 15611035
• MDR Text Key: 306618878
• Report Number: 2124215-2022-39631
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K020012
• 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: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 29417
• Device Catalogue Number: 29417
• Device Lot Number: 0028983638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2022
• 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: 72 YR
• Patient Sex: Female