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

Model Number M0061802230

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Date 02/28/2018

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(6).(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

It was reported to boston scientific corporation that a ureteral stent was used during a left ureteroscopy surgery with laser lilhotripsy stone removal and stent placement procedure in the left kidney, performed on (b)(6) 2018.As reported by the patient's attorney, on (b)(6) 2018, another surgery was performed to attempt to remove the 6 french x 26 cm stent.The surgery was unsuccessful to remove the ureteral stent and the broken stent remained inside the patient as reported by the patient's attorney, on (b)(6) 2019, a left hand assisted nephrectomy (kidney removal) procedure was performed.The removed kidney was sent for analysis and a portion of a protruding blue stent was noticed.Boston scientific has been unable to obtain additional information regarding the event.

Event Description

It was reported to boston scientific corporation that a ureteral stent was used during a left ureteroscopy surgery with laser lilhotripsy stone removal and stent placement procedure in the left kidney, performed on (b)(6), 2018.As reported by the patient's attorney, on (b)(6), 2018, another surgery was performed to attempt to remove the 6 french x 26 cm stent.The surgery was unsuccessful to remove the ureteral stent and the broken stent remained inside the patient as reported by the patient's attorney, on (b)(6), 2019, a left hand assisted nephrectomy (kidney removal) procedure was performed.The removed kidney was sent for analysis and a portion of a protruding blue stent was noticed.Boston scientific has been unable to obtain additional information regarding the event.** additional information received on (b)(6), 2020 ** the device was reported to be a contour ureteral stent.The contour ureteral stent was reported to have been implanted in the left ureter.

Manufacturer Narrative

Block e1: this event was reported by the patient's legal representation.The device was implanted at: (b)(6).Block h6: device code 1069 captures the reportable event of stent break.Device code 1528 captures the reportable event of stent difficult to remove.Patient code 3165 captures the reportable event of device fragments in patient.Patient code 3191 captures the reportable event for surgery.Conclusion code 4316 is being used in lieu of an adequate conclusion code for "device not returned" block h10: 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.Additional information: block d4; h4.

• Brand Name: CONTOUR
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10155239
• MDR Text Key: 195238699
• Report Number: 3005099803-2020-02308
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• PMA/PMN Number: K974541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 07/20/2020

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 Expiration Date: 10/16/2020
• Device Model Number: M0061802230
• Device Catalogue Number: 180-223
• Device Lot Number: 0021266665
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/22/2020
• Initial Date FDA Received: 06/15/2020
• Supplement Dates Manufacturer Received: 06/29/2020
• Supplement Dates FDA Received: 07/20/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR