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

Model Number	M006185156010
Medical Device Problem Codes	Calcified (1077); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however it was reported that the patient was over the age of 18.Block h6: imdrf device code a040501 captures the reportable event of stent calcified.Imdrf device code a150207 captures the reportable event of stent difficult to remove.Imdrf impact code f23 captures the reportable event of unexpected medical intervention.
Event or Problem Description
It was reported to boston scientific corporation that a stretch vl ureteral stent was used during a ureteroscopic lithotripsy with cystoscope procedure in the ureter on (b)(6) 2023.During routine follow-up, a planned stent removal procedure was performed on (b)(6) 2023.During this procedure, the physician found encrustation on the stent, and the stent could not be removed with a cystoscope.The physician had to use a laser for stone removal and to break up the encrustation on the stent in order for the stent to be removed.The procedure was completed, and the stent was successfully removed.Another stent was not placed during the procedure.There were no patient complications reported as a result of this event.A media of the complaint device was provided showing the calcified stent.
Event or Problem Description
It was reported to boston scientific corporation that a stretch vl ureteral stent was used during a ureteroscopic lithotripsy with cystoscope procedure in the ureter on (b)(6) 2023.During routine follow-up, a planned stent removal procedure was performed on (b)(6) 2023.During this procedure, the physician found encrustation on the stent, and the stent could not be removed with a cystoscope.The physician had to use a laser for stone removal and to break up the encrustation on the stent in order for the stent to be removed.The procedure was completed, and the stent was successfully removed.Another stent was not placed during the procedure.There were no patient complications reported as a result of this event.A media of the complaint device was provided showing the calcified stent.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however it was reported that the patient was over the age of 18.Block h6: imdrf device code a040501 captures the reportable event of stent calcified.Imdrf device code a150207 captures the reportable event of stent difficult to remove.Imdrf impact code f23 captures the reportable event of unexpected medical intervention.Block h10: the stretch vl ureteral stent was not returned, however, 1 photo and 3 videos were provided, and it was observed that residues were along the stent.It is unable to determine if it was a cause of infection or calcification.No other problems were observed.The reported event was not confirmed.Based on all the information provided, most likely, some operational factors, handling/manipulation with an excess of force could have contributed to the failure.Additionally, without proper evaluation of the device, it remains unknown what the most probable cause could have contributed to the event.Therefore, cause not establish is selected as the most probable root cause for the complaint.A review of the manufacturing documentation for this reveled that no anomalies or deviations related to the event occurred during manufacturing.H3 other text : media analysis.

• Brand Name: STRETCH VL
• Common Device Name: TUBE, DRAINAGE, SUPRAPUBIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17211206
• Report Number: 3005099803-2023-03476
• Device Sequence Number: 15014867
• Product Code: FAD
• UDI-Device Identifier: 08714729160816
• UDI-Public: 08714729160816
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K944290
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2023

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: 08/03/2026
• Device Model Number: M006185156010
• Device Catalogue Number: 185-156-01
• Device Lot Number: 0030208032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2023
• Supplement Date Received by Manufacturer: 07/03/2023
• Initial Report FDA Received Date: 06/27/2023
• Supplement Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2022
• 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: Required Intervention
• Patient Sex: Female
• Patient Race: Asian