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 07/12/2021

Event Type  malfunction  

Manufacturer Narrative

(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 ureterolithiasis procedure performed on (b)(6) 2021.During unpacking, the distal tip was found peeled off.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 to be used in the ureter during a ureterolithiasis procedure performed on (b)(6) 2021.During unpacking, the distal tip was found peeled off.The procedure was completed with another stone cone.No patient complications were reported as a result of this event.

Manufacturer Narrative

Block e1: initial reporter facility name: (b)(6) co., ltd.This event was reported by the distributor.The physician present for this case was: dr.(b)(6) no.1 hospital of bmu (b)(6).Block h6: problem code a040506 captures the reportable event of coil peeled.Block h10: the returned stone cone retrieval coil was analyzed, and a functional evaluation noted that the blue outer sheath was able to move effectively to advance and retract the coil.However, the coating on the distal tip of the device was partially removed and the device bent at an angle when the coil was fully advanced.The reported event was confirmed.Based on all available information, it is likely that the user encountered difficulty during the procedure when rotating the coil, which can lead to bending of the working length.This likely also resulted in the analyzed damage to the coating of the distal tip.The user might have observed the coating damage after getting the device outside the patient.Therefore, the most probable root cause for the failure reported and the failures discovered during analysis is unintended use error.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / 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: 12281724
• MDR Text Key: 265199643
• Report Number: 3005099803-2021-03949
• 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: 10/11/2021

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 Expiration Date: 01/10/2023
• Device Model Number: M0063903200
• Device Catalogue Number: 390-320
• Device Lot Number: 0005225783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Initial Date Manufacturer Received: 07/13/2021
• Initial Date FDA Received: 08/05/2021
• Supplement Dates Manufacturer Received: 09/16/2021
• Supplement Dates FDA Received: 10/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 58