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

Model Number	M006185157080
Medical Device Problem Codes	Difficult to Remove (1528); Material Deformation (2976); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	10/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Imdrf device problem code a150207 captures the reportable event of stent difficult to remove.Imdrf device problem code a0406 captures the reportable event of stent deformed and knotted.Imdrf device problem code a0414 captures the reportable event of stent torn.
Event or Problem Description
It was reported that, around (b)(6) 2024, during transurethral lithotripsy procedure a stretch vl ureteral stent was used.Upon unpacking, a kink between the stent coils was observed; however, the stent was successfully placed from the renal pelvis into the bladder.On (b)(6) 2024, an attempt was made to remove the stent, but a knot had formed at the tip and developed stitches on the renal pelvis and was difficult to remove.Another removal attempt was made, and it was successfully removed.No further patient complications were reported.

• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 20631349
• Report Number: 2124215-2024-69956
• Device Sequence Number: 15489775
• Product Code: FFA
• UDI-Device Identifier: 08714729297765
• UDI-Public: 08714729297765
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K944290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 11/07/2024

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: Health Professional
• Device Model Number: M006185157080
• Device Catalogue Number: 185-157-08
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 11/07/2024
• 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
• Patient Sex: Unknown