MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXIMA; TUBE, DRAINAGE, SUPRAPUBIC

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

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

Event Date 06/24/2022

Event Type  malfunction  

Event Description

It was reported that this nephrostomy catheter tip had broken off.A flexima catheter was selected for use as a nephrostomy drainage catheter.The patient noticed that the catheter had become displaced and the tip of the catheter (proximal to the sutures) was broken off.It was noted that a photo showed the pigtail tip of the catheter intact.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Event date was approximated to (b)(6) 2022 based on the date the manufacturer became aware of the event.(b)(6).

Manufacturer Narrative

B3: event date was approximated to 07/01/2022 based on the date the manufacturer became aware of the event.E1: facility name: (b)(6).

Event Description

It was reported that this nephrostomy catheter tip had broken off.An unknown flexima catheter was selected for use as a nephrostomy drainage catheter.The patient noticed that the catheter had become displaced and the tip of the catheter (proximal to the sutures) was broken off.It was noted that a photo showed the pigtail tip of the catheter intact.There were no patient complications reported as a result of this event.Additional information indicated that an x-ray was performed and confirmed that no remaining catheter was left inside the patient.The patient was reassured, x-ray performed, blood tests including u+es, urine dip and msu sent.Case was discussed with urology and referral accepted by urology team.

• Brand Name: FLEXIMA
• Type of Device: TUBE, DRAINAGE, SUPRAPUBIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 15218468
• MDR Text Key: 305172284
• Report Number: 3005099803-2022-04324
• Device Sequence Number: 1
• Product Code: GBO
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/25/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/18/2022
• Initial Date FDA Received: 08/12/2022
• Supplement Dates Manufacturer Received: 04/12/2023
• Supplement Dates FDA Received: 04/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1