MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORP. BOSTON SCIENTIFIC CORP.; NEPHROSTOMY TUBE

Catalog Number 10FRX25CM M001245270

Device Problems Detachment Of Device Component (1104); Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/17/2017

Event Type  Injury  

Event Description

Physician was performing a right nephrostomy tube exchange on a (b)(6)pregnant.As the catheter was being removed, it fractured and part of it broke off in the soft tissue.The physician was unable to retrieve it after multiple attempts.The pt and her mother were informed of the incident.The tube is moving towards the skin which may make it easier to retrieve.The pt was given the option at that time to return the operating room for retrieval but chose to wait.A new 10 french tube was reinserted and sutured in place.This may be a known complication.

• Brand Name: BOSTON SCIENTIFIC CORP.
• Type of Device: NEPHROSTOMY TUBE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORP.; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 7305659
• MDR Text Key: 101493029
• Report Number: MW5075592
• Device Sequence Number: 1
• Product Code: GBO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10FRX25CM M001245270
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR
• Patient Weight: 222