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

Model Number M0063903200

Device Problems Break (1069); Difficult to Open or Close (2921)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/17/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter facility name (b)(6).This event was reported by the dealer.The physician present for this case was: (b)(6).(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 to be used in the ureter during a ureteroscopic lithotripsy procedure performed on (b)(6) 2021.During preparation, the physician attempted to deploy the device but failed.Moreover, the sheath broke at the distal part of the stone cone.The procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient's condition following procedure was reported to be stable.

Manufacturer Narrative

Block e1: initial reporter facility name is (b)(6).Initial reporter address 1 is (b)(6).Block e1: this event was reported by the dealer.The physician present for this case was: dr.(b)(6).Block h6: problem code a0401 captures the reportable event of sheath break.Block h10: the returned stone cone was analyzed, and a visual analysis found the coil was exposed.The proximal end of the blue sheath was torn/damaged.It appeared that the proximal end of the sheath had been forced over the proximal stop.The sheath was opened further than the limit such that the distal end of the sheath passed the end of the green coil coating.The defects prevented the device from being able to close properly during functional testing.The reported event was confirmed.Based on all available information, it is likely that while testing the device before use, excessive force on the outer sheath caused it to extend past the positive stop, contradicting the instruction to advance the sheath to the positive stop, and the coil was not able to open or close.Product investigation showed the sheathe was extended past the distal stop and the coil was unable to be opened.It is likely that while testing the device before use, excessive force on the outer sheath caused it to extend past the positive stop, contradicting the instruction to advance the sheath to the positive stop, and the coil was not able to open or close.The instructions for use (ifu) provides instructions for testing the device prior to use and states "prior to use, ensure that the coil is working properly by advancing the sheath over the coil to the positive stop and then retracting the sheath to open the coil.The sheath of the device should be straight during testing." therefore, the most probable root cause is failure to follow instructions a labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

Event Description

It was reported to boston scientific corporation that a stone cone nitinol retrieval coil was to be used in the ureter during a ureteroscopic lithotripsy procedure performed on (b)(6) 2021.During preparation, the physician attempted to deploy the device but failed.Moreover, the sheath broke at the distal part of the stone cone.The procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient's condition following procedure was reported to be stable.

• Brand Name: STONE CONE
• Type of Device: DISLODGER, STONE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): LAKE REGION MEDICAL; 31c butterfield trail; el paso TX 79906
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12624285
• MDR Text Key: 276188943
• Report Number: 3005099803-2021-05286
• Device Sequence Number: 1
• Product Code: FGO
• UDI-Device Identifier: 08714729430223
• UDI-Public: 08714729430223
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2023
• Device Model Number: M0063903200
• Device Catalogue Number: 390-320
• Device Lot Number: 0005676466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2020
• 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
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 67 KG