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

Model Number M0061802220

Device Problem Migration (4003)

Patient Problems Nausea (1970); Pain (1994)

Event Date 09/27/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Conclusion is being used in lieu of an adequate conclusion code for device not returned.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 contour ureteral stent was implanted during a left ureteroscopy, laser lithotripsy, basket stone extraction, retrograde pyelogram, and ureteral stent insertion procedure performed in the left ureter for treatment of left ureteral calculus on (b)(6) 2018.According to the complainant, post procedure the very same evening, the stent was reported to have fell out of position.The patient was reported to have had severe flank pain and nausea and was admitted to the hospital overnight.The patient was reported to have been good on pod1 and office cystoscopy to remove the stent from her bladder was performed immediately following discharge.There was no serious injury or adverse patient effects reported as a result of this event, and the patient's condition at the conclusion of the procedure was reported to be good.

• 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 DE COSTA RICA S.R.L.; 2546 calle primera; propark, coyol,; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; ,; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 8062329
• MDR Text Key: 126901709
• Report Number: 3005099803-2018-61328
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729058502
• UDI-Public: 08714729058502
• 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: 11/12/2018

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: 05/01/2021
• Device Model Number: M0061802220
• Device Catalogue Number: 180-222
• Device Lot Number: 0022070443
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2018
• Initial Date FDA Received: 11/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2018
• 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
• Patient Age: 35 YR
• Patient Weight: 88