MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DUAL LUMEN URETERAL CATHETER; CATHETER, UROLOGICAL

Model Number	M0064051000
Medical Device Problem Codes	Entrapment of Device (1212); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a dual lumen ureteral catheter was used in the right ureter/kidney during a cysto ureteroscopy laser lithotripsy procedure on (b)(6) 2022.During procedure, when catheter was removed, the guidewire frayed, and it got stuck inside the dual lumen catheter.The procedure was completed with a new amplatz super stiff.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation results: tip torn.
Additional Manufacturer Narrative
Device code a24 captures the reportable investigation result of tip torn.Investigation result: the returned dual lumen ureteral catheter was analyzed and a visual examination found that the catheter with the guidewire was stuck.Microscopic evaluation of the device revealed that the tip was torn.Functional inspection was done by removing the guidewire and a mandrel of 0.039" was passed to both lumens successfully.It was noted that no resistance was felt.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of guidewire stuck was confirmed.The guidewire that got stuck in the dual lumen catheter is likely to have occurred due to the interaction and/or handling between the device and the guidewire during the procedure.Therefore, the most probable root cause is adverse event related to procedure.

• Brand Name: DUAL LUMEN URETERAL CATHETER
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16385282
• Report Number: 3005099803-2023-00818
• Device Sequence Number: 14731007
• Product Code: KOD
• UDI-Device Identifier: 08714729012689
• UDI-Public: 08714729012689
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K860337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/16/2023

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: M0064051000
• Device Catalogue Number: 405-100
• Device Lot Number: 0030358356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2022
• 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
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 54 KG