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

Model Number M0061801560

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/13/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a contour stent is to be used during a ureter dilatation in the kidney, performed on (b)(6) 2019.According to the complainant, during unpacking, it was noticed that the contour stent was not inside the sterile bag and the sterility of the device was compromised.The device was not used in the procedure and there was no serious injury, nor were there any adverse patient effects reported as a result of this event.

• Brand Name: CONTOUR VL
• 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: 8691369
• MDR Text Key: 147738143
• Report Number: 3005099803-2019-03010
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729067986
• UDI-Public: 08714729067986
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K974541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/12/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 01/20/2022
• Device Model Number: M0061801560
• Device Catalogue Number: 180-156
• Device Lot Number: 0023221991
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/13/2019
• Initial Date FDA Received: 06/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2019
• 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