MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CONTOUR; STENT, URETERAL

Model Number	M006180522180
Medical Device Problem Codes	Material Integrity Problem (2978); Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event was approximated to (b)(6) 2021 based on the date the manufacturer became aware of the event.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(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
Note: this report is two of two complaints that pertain to the same event (mfr report # 3005099803-2021-02326 and mfr.Report # 3005099803-2021-02329).It was reported that a contour ureteral stent was used during a stent placement procedure to help protect the ureter as the patient underwent abdominal surgery on an unknown date.The patient was intubated in the icu prior to procedure.During the procedure, two contour ureteral stents were implanted bilaterally and failed to coiled.Both stents were left implanted in the patient.On an unknown date both bilateral contour ureteral stents slipped out of the patient and had to be retrieved via cystoscopy by the physician.

• Brand Name: CONTOUR
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11845136
• Report Number: 3005099803-2021-02329
• Device Sequence Number: 3425168
• Product Code: FAD
• UDI-Device Identifier: 08714729789284
• UDI-Public: 08714729789284
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K974541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/18/2021

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 Model Number: M006180522180
• Device Catalogue Number: 180-522-18
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 05/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention