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

Model Number	M0061802210
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.It was reported the device was not used past its expiry.(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 an contour ureteral stent was used during an ureteroscopy w/ stent placement procedure in the kidney, ureter and bladder, performed on (b)(6) 2020.According to the complainant, when the circulating nurse was unpacking the outer box, the wrapper tore across the package and accidentally tore the sterile pouch compromising the sterility of the device.Another contour ureteral stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: device code 1444 captures the reportable event of packaging seal compromised.Block h10: the returned contour ureteral stent stent packaging was analyzed, and a visual evaluation noted that the original pouch with the top section ripped / torn.The top section pouch was not returned and the original pouch label was ripped /torn at top corner section.The integrity of the inner package and the device inside the pouch are without issues.No other issues with the device were noted.The reported event was not confirmed.Based on product analysis, and all compiled information, it is possible that the way in which the device was handled and manipulated may have contributed to the encountered failure pouch ripped torn and the defect noted may appear due to some aspect of shipping/ handling/ storage of the product.Therefore, adverse event related to procedure is selected for the most probable cause for the complaint.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A search of the complaint database confirmed that no similar complaints exist for the specified lot.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that an contour ureteral stent was used during an ureteroscopy w/ stent placement procedure in the kidney, ureter and bladder, performed on (b)(6) 2020.According to the complainant, when the circulating nurse was unpacking the outer box, the wrapper tore across the package and accidentally tore the sterile pouch compromising the sterility of the device.Another contour ureteral stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.

• Brand Name: CONTOUR
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9836405
• Report Number: 3005099803-2020-00932
• Device Sequence Number: 1299715
• Product Code: FAD
• UDI-Device Identifier: 08714729058472
• UDI-Public: 08714729058472
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K974541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2020

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: 09/18/2022
• Device Model Number: M0061802210
• Device Catalogue Number: 180-221
• Device Lot Number: 0024461232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2020
• Initial Date Received by Manufacturer: 02/20/2020
• Supplement Date Received by Manufacturer: 04/03/2020
• Initial Report FDA Received Date: 03/16/2020
• Supplement Report FDA Received Date: 04/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1