MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STONE CONE; DISLODGER, STONE, FLEXIBLE

Model Number M0063903200

Device Problems Peeled/Delaminated (1454); Difficult to Advance (2920); Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 03/01/2021

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.However, the complainant reported that the device was not expired.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a stone cone nitinol retrieval coil was used in the ureter during a lithotripsy procedure performed on (b)(6) 2021.During the procedure, the stone cone device was inserted into the ureteroscope.However, resistance was noted when attempting to straighten the coil.The physician kept pushing the stone cone towards the end of the scope but the coil could not come out from the distal end of the scope.The stone cone was removed instead and found the coil has bent and peeled, as confirmed by a photo submitted by the customer.The procedure was completed with another stone cone.No patient complications were reported as a result of this event.

Event Description

It was reported to boston scientific corporation that a stone cone nitinol retrieval coil was used in the ureter during a lithotripsy procedure performed on (b)(6), 2021.During the procedure, the stone cone device was inserted into the ureteroscope.However, resistance was noted when attempting to straighten the coil.The physician kept pushing the stone cone towards the end of the scope but the coil could not come out from the distal end of the scope.The stone cone was removed instead and found the coil has bent and peeled, as confirmed by a photo submitted by the customer.The procedure was completed with another stone cone.No patient complications were reported as a result of this event.

Manufacturer Narrative

Block d4, h4: 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.Block h6: device code a040506 captures the reportable event of coil peeled.Block h10: the returned stone cone was analyzed, and a visual evaluation noted that the distal tip was bent and damaged, and the coating was partially removed from the distal tip and the coil.The blue outer sheath was unable to move due to the damaged coating on the coil.There was no evidence of melting or scorching around the damage, so it was unlikely due to laser interaction.No other problems with the device were noted.The reported event was confirmed.Based on all available information, it is likely that the user encountered difficulty during the procedure.The damage noted during product analysis was likely caused by interaction with other devices during the procedure.This likely could have led to coating damage of the distal tip.Therefore, the most probable root cause is adverse event related to procedure.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.

• Brand Name: STONE CONE
• Type of Device: DISLODGER, STONE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11610649
• MDR Text Key: 243685882
• Report Number: 3005099803-2021-01371
• Device Sequence Number: 1
• Product Code: FGO
• UDI-Device Identifier: 08714729430223
• UDI-Public: 08714729430223
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/07/2021

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 Model Number: M0063903200
• Device Catalogue Number: 390-320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Initial Date Manufacturer Received: 03/08/2021
• Initial Date FDA Received: 04/02/2021
• Supplement Dates Manufacturer Received: 05/10/2021
• Supplement Dates FDA Received: 06/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1