MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION URETERAL STENT POSITIONER; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M0061802011
Medical Device Problem Codes	Defective Device (2588); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a ureteral stent positioner was open to be used during a procedure, performed on (b)(6) 2020.According to the complainant, when the physician unpacked the package, it was noticed that the stent positioner was broken.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a ureteral stent positioner was open to be used during a procedure, performed on (b)(6) 2020.According to the complainant, when the physician unpacked the package, it was noticed that the stent positioner was broken.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: medical device problem code a27 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: the returned ureteral stent positioner was analyzed, and a visual evaluation noted that the positioner broke in two parts.The device was out of the original pouch and the picture submitted with the event showed an ureteral stent positioner broken in two parts inside of the pouch.It is not possible to confirm whether the pouch is opened or closed and therefore if the device was manipulated or not.No other problems with the device were noted.The reported event was confirmed.The analysis of the returned device revealed that the positioner was broken in two parts.The photo submitted with the event shows the positioner inside the pouch and the positioner was returned out of the original pouch.It was also possible to find evidence of a pression cut of the positioner, which could have been caused by interaction/handling/manipulation of the device.Therefore, adverse event related to procedure is the most probable root cause for the complaint since it is the most likely that the adverse event occurred during the procedure and the device had no influence on event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Block h11: correction to field h6 (device code) upon review of the complaint.

• Brand Name: URETERAL STENT POSITIONER
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11269937
• Report Number: 3005099803-2021-00332
• Device Sequence Number: 4607263
• Product Code: FGE
• UDI-Device Identifier: 08714729041245
• UDI-Public: 08714729041245
• Combination Product (Y/N): N
• Initial Reporter Country: BX
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2021

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: Health Professional
• Device Expiration Date: 07/10/2023
• Device Model Number: M0061802011
• Device Catalogue Number: 180-201
• Device Lot Number: 0024091469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 05/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1