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

Model Number	M0061851550
Medical Device Problem Codes	Calcified (1077); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient is reported to be older than 18 years old.(b)(6).(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a stretch vl ureteral stent was used during a procedure in the ureter, performed on (b)(6) 2021.During a planned stent removal procedure on (b)(6) 2021, it was noticed that stones were on the surface of the ureteral stent, resulting in difficulty removing of the stent.The stretch vl ureteral stent was removed under visual view of ureteroscopy and holmium laser lithotripsy.It was unknown if a new stent was implanted.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation that a stretch vl ureteral stent was used during a procedure in the ureter, performed on (b)(6), 2021.During a planned stent removal procedure on (b)(6), 2021, it was noticed that stones were on the surface of the ureteral stent, resulting in difficulty removing of the stent.The stretch vl ureteral stent was removed under visual view of ureteroscopy and holmium laser lithotripsy.It was unknown if a new stent was implanted.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6) block h6: medical device problem code a040501 captures the reportable event of stent calcified.Medical device problem code a150207 captures the reportable event of stent difficult to remove.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: according to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.Block h11: correction to d7a (sud reprocessed and reused) correction to e1: updated initial reporter address 1; initial reporter address 2; initial reporter city; initial reporter zip/post code; initial reporter phone -(b)(6)correction to h6: evaluation conclusion codes.

• Brand Name: STRETCH VL
• Common Device Name: TUBE, DRAINAGE, SUPRAPUBIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12108115
• Report Number: 3005099803-2021-03179
• Device Sequence Number: 17188485
• Product Code: FAD
• UDI-Device Identifier: 08714729160786
• UDI-Public: 08714729160786
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K944290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2021

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
• Operator of Device: Other
• Device Expiration Date: 03/12/2023
• Device Model Number: M0061851550
• Device Catalogue Number: 185-155
• Device Lot Number: 0025348450
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/10/2021
• Supplement Date Received by Manufacturer: 07/17/2021
• Initial Report FDA Received Date: 07/02/2021
• Supplement Report FDA Received Date: 08/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR