MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) CONTOUR¿; STENT, URETERAL

Model Number	M0061802220
Medical Device Problem Codes	Break (1069); Calcified (1077); Difficult to Remove (1528)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).User medwatch # (b)(4).The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a contour stent was implanted in a patient on (b)(6) 2017, and was attempted to be removed during an eswl procedure performed on (b)(6) 2017.According to the complainant, during the procedure, a 22 french rigid cystoscope was passed into the urethra and bladder under direct vision and appeared to be normal.When entering the bladder, it was noticed that there was a large bladder stone, acute and chronic inflammation, and irritation of the bladder.However, no lesion associated with the bladder was observed.A 900 laser fiber at about 14 watts power was used to break the stone into multiple fragments, until the stent was completely exposed.An ellik evacuator was used to irrigate the fragments out of the bladder, and the process was repeated for 90 percent of the fragments.The stent was then grasped and the stent broke off just beyond the uterovesical junction.The stent was thought to have been weakened from the laser fiber, and was still embedded within the kidney stone.The patient was discharged home and scheduled for percutaneous nephrolithotomy for (b)(6) 2017 to remove his kidney stone and the remaining stent.

• Brand Name: CONTOUR¿
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 6798349
• Report Number: 3005099803-2017-02497
• Device Sequence Number: 1568742
• Product Code: FAD
• UDI-Device Identifier: 08714729058502
• UDI-Public: (01)08714729058502(17)20160201(10)15827945
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K974541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/21/2017

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: 02/01/2016
• Device Model Number: M0061802220
• Device Catalogue Number: 180-222
• Device Lot Number: 15827945
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2017
• Initial Report FDA Received Date: 08/16/2017
• 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: 84 YR
• Patient Weight: 81