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

Model Number M0063903200

Device Problem Peeled/Delaminated (1454)

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

Event Date 09/26/2022

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.(b)(4).

Event Description

It was reported to boston scientific corporation that a stone cone nitinol retrieval coil was used in the ureter during a ureteral stone crushing procedure performed on (b)(6) 2022.During the procedure, the coil was found cracked.Another stone cone was used to complete the procedure.There were no patient complications 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.Block h6: device code a040506 captures the reportable event of coil was cracked.Block h10: the returned trapezoid rx basket was analyzed, and a visual evaluation noted that the blue outer sheath was extended past the distal stop of the device.Furthermore, the cone was found to be inside the blue sheath as well.The sheath was not able to be moved and the coil could not be unsheathed as the distal stop created significant resistance.The reported complaint of "coil peeled" was not confirmed because visual inspection of the tip could not be performed during the product analysis because it was pushed into the blue sheath.Based on all available information, the risk documentation contains specifics about the reported event."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," according to the ifu.During testing, the device sheath should be straight." product investigation revealed that the sheath had been extended past the distal stop and that the coil was completely contained within the blue sheath.Excessive force on the outer sheath during testing and use is likely to have caused it to extend past the positive stop, contradicting the instruction to advance the sheath to the positive stop, and the coil to be unable to open or close.Therefore, the most probable root cause is unintended use error.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

Event Description

It was reported to boston scientific corporation that a stone cone nitinol retrieval coil was used in the ureter during a ureteral stone crushing procedure performed on (b)(6) 2022.During the procedure, the coil was found cracked.Another stone cone was used to complete the procedure.There were no patient complications reported as a result of this event.

• 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: 15649587
• MDR Text Key: 306917982
• Report Number: 3005099803-2022-06193
• Device Sequence Number: 1
• Product Code: FGO
• UDI-Device Identifier: 08714729430223
• UDI-Public: 08714729430223
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 12/15/2022

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2022
• Initial Date FDA Received: 10/21/2022
• Supplement Dates Manufacturer Received: 12/05/2022
• Supplement Dates FDA Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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