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 07/08/2021

Event Type  malfunction  

Manufacturer Narrative

(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 medwatch 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 transurethral ureteroscope ureteral pneumatic lithotripsy procedure performed on (b)(6) 2021.During the procedure, the coil of the stone cone device was peeled off as confirmed by a photo submitted by the customer.The procedure was completed with another stone cone.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block a4: weight is 62.5 kgs.Block h6: device code a040506 captures the reportable event of the coil was peeled.Block h10: the returned trapezoid rx basket was analyzed, and a visual evaluation noted that coil was exposed and tangled.The green coating of the coil was peeled near the distal end.Additionally, blood residue was found on the white inner working length toward the proximal end of the device near the handle, which gives evidence that the device was used on a patient.The reported event was confirmed.Based on all available information, it's most likely that the damage was caused due to procedural factors such as handling, technique, device manipulation or interaction with another device.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 instructions for use (ifu) / product label.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 that a stone cone nitinol retrieval coil was used in the ureter during a transurethral ureteroscope ureteral pneumatic lithotripsy procedure performed on (b)(6) 2021.During the procedure, the coil of the stone cone device was peeled off as confirmed by a photo submitted by the customer.The procedure was completed with another stone cone.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: 12353992
• MDR Text Key: 267674954
• Report Number: 3005099803-2021-04301
• 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: Non-Healthcare Professional
• 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: 08/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/16/2022
• Device Model Number: M0063903200
• Device Catalogue Number: 390-320
• Device Lot Number: 0005201413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Date Manufacturer Received: 12/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2019
• 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: 62 YR
• Patient Sex: Male