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

Model Number M001271810

Device Problem Difficult to Insert (1316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/19/2019

Event Type  malfunction  

Event Description

Unable to insert plastic stiffener.There is a plastic burr at the hub connection.Manufacturer response for flexima catheter, (brand not provided) (per site reporter).Issued rga#, sent return kit, sent replacement product.

• Brand Name: FLEXIMA
• Type of Device: CATHETER, NEPHROSTOMY, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 8830982
• MDR Text Key: 152389004
• Report Number: 8830982
• 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: 07/02/2019

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: Other
• Device Model Number: M001271810
• Device Catalogue Number: M001271810
• Device Lot Number: 22214055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/02/2019
• Event Location: Hospital
• Date Report to Manufacturer: 07/26/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 34675 DA