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

Model Number	M006180157010
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2018 as no event date was reported.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.(b)(4).The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a contour stent was implanted during a ureteroscopy with stone fragmentation and double j implantation procedure.The event date was not provided.According to the complainant, during withdrawal, it was noticed that the stent was encrusted.There were no patient complications reported as a result of this event.The patients condition at the conclusion of the procedure was noted to be stable.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that a contour stent was implanted during a ureteroscopy with stone fragmentation and double j implantation procedure.The event date was not provided.According to the complainant, during withdrawal, it was noticed that the stent was encrusted.There were no patient complications reported as a result of this event.The patients condition at the conclusion of the procedure was noted to be stable.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.Additional information received on 12november2018.It was reported that the patient did not undergo regular checkups with the implanted stent, and although the stent was encrusted it was able to drain.The stent was reported to have been implanted in early october and was explanted in mid october.The stent was not removed earlier than the scheduled stent removal date.The suture was not left on the stent and the stent was removed in its entirety with the use of grasping forceps.
Additional Manufacturer Narrative
Additional information block b5 updated.Block h6: conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.Block h11: correction to e1: initial reporter facility name from (b)(6) hospital to (b)(6) medical center, initial reporter city from (b)(6).
Event or Problem Description
It was reported to boston scientific corporation that a contour stent was implanted during a ureteroscopy with stone fragmentation and double j implantation procedure.The event date was not provided.According to the complainant, during withdrawal, it was noticed that the stent was encrusted.There were no patient complications reported as a result of this event.The patients condition at the conclusion of the procedure was noted to be stable.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.Additional information received on 12november2018.It was reported that the patient did not undergo regular checkups with the implanted stent, and although the stent was encrusted it was able to drain.The stent was reported to have been implanted in early (b)(6) and was explanted in mid (b)(6).The stent was not removed earlier than the scheduled stent removal date.The suture was not left on the stent and the stent was removed in its entirety with the use of grasping forceps.

• Brand Name: CONTOUR VL
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8064112
• Report Number: 3005099803-2018-61401
• Device Sequence Number: 1953694
• Product Code: FAD
• UDI-Device Identifier: 08714729058434
• UDI-Public: 08714729058434
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: K974541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M006180157010
• Device Catalogue Number: 180-157-01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/19/2018
• Supplement Date Received by Manufacturer: 11/12/2018; 12/24/2018
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 12/04/2018; 01/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1