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

Model Number	M0061802220
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Nausea (1970); Pain (1994)
Date of Event	09/27/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8062329
• Report Number: 3005099803-2018-61328
• Device Sequence Number: 14173022
• Product Code: FAD
• UDI-Device Identifier: 08714729058502
• UDI-Public: 08714729058502
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K974541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 11/12/2018
• 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
• Patient Age: 35 YR
• Patient Weight: 88