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

Model Number	32375
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	06/29/2023
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 2124215-2023-37697
• Device Sequence Number: 5955609
• Product Code: GBO
• UDI-Device Identifier: 08714729323303
• UDI-Public: 08714729323303
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 01/05/2026
• 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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/06/2023
• Supplement Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 07/31/2023
• Supplement Report FDA Received Date: 08/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Weight: 66 KG