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

Model Number M006180522180

Device Problems Material Integrity Problem (2978); Migration (4003)

Patient Problem Insufficient Information (4580)

Event Date 04/01/2021

Event Type  Injury  

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 Description

Note: this report is one 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
• Type of Device: STENT, URETERAL
• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 11845272
• MDR Text Key: 251391595
• Report Number: 3005099803-2021-02326
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729789284
• UDI-Public: 08714729789284
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: M006180522180
• Device Catalogue Number: 180-522-18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2021
• Initial Date FDA Received: 05/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention