MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXIMA¿; CATHETER, NEPHROSTOMY, GENERAL PLASTIC SURGERY

Model Number M001271810

Device Problems Material Twisted/Bent (2981); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 11/30/2021

Event Type  malfunction  

Event Description

Catheter was implanted yesterday (late november), and the patient noticed a kink and blood.Doctor removed original catheter and implanted a new one.

• Brand Name: FLEXIMA¿
• Type of Device: CATHETER, NEPHROSTOMY, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12922706
• MDR Text Key: 281670776
• Report Number: 12922706
• Device Sequence Number: 1
• Product Code: GBO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/01/2021

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 Model Number: M001271810
• Device Catalogue Number: M001271810
• Device Lot Number: 27965238
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/01/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/03/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24090 DA
• Patient Sex: Male
• Patient Weight: 84 KG