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 11/28/2022

Event Type  malfunction  

Event Description

It was reported that the catheter was broken.A 105/3.0/2.5/.021/20 renegade microcatheter was selected for use.Upon unpacking, it was noted that the catheter was broken.The procedure was completed with another of the same device.No complications reported and patient was stable.

Manufacturer Narrative

Device evaluated by mfr: the complaint device was received for product analysis.The device was visually and microscopically inspected for damage.The device showed damage in the form of a stretched and fractured shaft located 7.3cm from the hub.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The device was confirmed for stretching and a fracture.No other issues were identified during the product analysis.

Event Description

It was reported that the catheter was broken.A 105/3.0/2.5/.021/20 renegade microcatheter was selected for use.Upon unpacking, it was noted that the catheter was broken.The procedure was completed with another of the same device.No complications reported and patient was stable.

• 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: 16005181
• MDR Text Key: 307920982
• Report Number: 2124215-2022-53361
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 08714729375395
• UDI-Public: 08714729375395
• 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: 02/07/2023

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 Model Number: 29417
• Device Catalogue Number: 29417
• Device Lot Number: 0028807812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2022
• Initial Date FDA Received: 12/19/2022
• Supplement Dates Manufacturer Received: 01/18/2023
• Supplement Dates FDA Received: 02/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2022
• 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