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

Model Number 32375

Device Problem Break (1069)

Patient Problem Perforation (2001)

Event Date 06/29/2023

Event Type  Injury  

Event Description

It was reported that the stiffener got detached and perforated the kidney hilum.The target lesion was located in the kidney area.A flexima catheter drainage was selected for use.During the procedure, it was noted that the hub of the stiffener got detached, causing the stiffener to advance the catheter and perforate the kidney hilum.The device was removed with ease.A new nephrostomy tube was placed, since the perforated renal pelvis will heal on its own.The physician reviewed the ct and there was no blood vessel medial to the site of perforation.No patient complications were reported.

Manufacturer Narrative

The device was returned to boston scientific for analysis.The product was returned with its original pouch and the pouch information matches with the complaint information.Visual inspection revealed that only the hub cannula and an accessory were returned for analysis.This confirms that the metal cannula, which was not returned, was separated from the hub.No further issues were observed.

Event Description

It was reported that the stiffener got detached and perforated the kidney hilum.The target lesion was located in the kidney area.A flexima catheter drainage was selected for use.During the procedure, it was noted that the hub of the stiffener got detached, causing the stiffener to advance the catheter and perforate the kidney hilum.The device was removed with ease.A new nephrostomy tube was placed, since the perforated renal pelvis will heal on its own.The physician reviewed the ct and there was no blood vessel medial to the site of perforation.No patient complications were reported.Device evaluated by manufacturer: the device was returned for analysis.Visual inspection was performed.Only hub cannula and an accessory were returned for analysis.It is evidencing the separation of the metal cannula from the hub.The pouch was returned, and it was observed that the pouch information matches with the complaint information.No issues were observed in the devices.

• Brand Name: FLEXIMA
• Type of Device: TUBE, DRAINAGE, SUPRAPUBIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17426226
• MDR Text Key: 320069082
• Report Number: 2124215-2023-37697
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 08714729323303
• UDI-Public: 08714729323303
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 32375
• Device Catalogue Number: 32375
• Device Lot Number: 0030802191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2023
• Initial Date FDA Received: 07/31/2023
• Supplement Dates Manufacturer Received: 08/08/2023
• Supplement Dates FDA Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2023
• 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 Outcome(s): Other
• Patient Weight: 66 KG