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

Model Number M0061802210

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2020

Event Type  malfunction  

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 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.

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 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
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9836405
• MDR Text Key: 191273614
• Report Number: 3005099803-2020-00932
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729058472
• UDI-Public: 08714729058472
• Combination Product (y/n): N
• PMA/PMN Number: K974541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 02/20/2020
• Initial Date FDA Received: 03/16/2020
• Supplement Dates Manufacturer Received: 04/03/2020
• Supplement Dates FDA Received: 04/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1