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

Model Number	M006180155170
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/23/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported to boston scientific corporation that a contour vl stent was opened for use for a procedure to be performed in the kidney on (b)(6) 2018.According to the complainant, during unpacking, it was noticed that the stent was broken into two pieces along the shaft of the stent.The procedure was completed with another contour vl stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
Additional Manufacturer Narrative
Correction to model number from 64335 to m006180155170.Correction to mfr contact first name from (b)(6) to (b)(6) and added (b)(6) to mfr contact last name.Correction to device problem code.Problem code 1069 captures the reportable event of stent shaft break.
Event or Problem Description
It was reported to boston scientific corporation that a contour vl stent was opened for use for a procedure to be performed in the kidney on (b)(6) 2018.According to the complainant, during unpacking, it was noticed that the stent was broken into two pieces along the shaft of the stent.The procedure was completed with another contour vl stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

• 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: 7791847
• Report Number: 3005099803-2018-60062
• Device Sequence Number: 19420159
• Product Code: FAD
• UDI-Device Identifier: 08714729765806
• UDI-Public: 08714729765806
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 10/18/2018

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 Expiration Date: 12/31/2020
• Device Model Number: M006180155170
• Device Catalogue Number: 64335
• Device Lot Number: 0021945964
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/23/2018
• Supplement Date Received by Manufacturer: 09/24/2018
• Initial Report FDA Received Date: 08/16/2018
• Supplement Report FDA Received Date: 10/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1