MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTATABLE SNARE; SNARE, FLEXIBLE

Model Number M00561821

Device Problems Break (1069); Mechanical Problem (1384); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/14/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).Investigation results: visual analysis of the returned product revealed that the device extends and retracts within specification.However, it was noted under magnification that the tip of the loop present a foreign substance, and the wires in this section was broken.A foreign matter was observed on the tip and this is reducing the width of the loop.The loop measurement is 8 mm which should be 13 mm.Testing was performed to identify the foreign substance found on the loop and it was found that the substance is a polyethylene oxide.This material is not used during the manufacturing process as there is only two chemical compounds used during manufacturing operations: loctite #4031 and mdx- heptane blend (n-heptane and mdx4-4159 silicone fluid) and none of them has polyethylene oxide or protein.Based on the information available and the analysis performed, the most probable root cause is cause not established, since the investigation findings do not lead to a clear conclusion about the cause of the adverse event.On the other hand, analysis was performed on the broken wires in the loop, and as per results, the wires exhibit signs of ductile failure, including micro-void coalescence.Failure mode appears to be ductile overload due to bending and torsional forces.There is evidence of a sharp object in contact with several of the wires and it is hypothesized that this damage may have contributed to the failure.As per complaint information the issue occurred during procedure.It is most probable that during the procedure, operational factors such as user technique or handling, contributed to fracture the loop wires.Since the event occurred during the procedure, the device had no influence on this failure.Therefore, the most probable root cause for this problem is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

Event Description

It was reported to boston scientific corporation that a rotatable small oval med stiff snare was to be used during an unknown procedure performed on (b)(6) 2019.According to the complainant, during procedure and inside the patient, when the snare was opened inside the body, the snare would not expand completely.The opening width was measured and it was only 9mm which is smaller from the usual labeled size.The procedure was completed with another rotatable snare.There were no patient complications reported as a result of this event.Note: this event has been deemed an mdr-reportable event based on the investigation results which revealed that a foreign substance was present at the tip of the loop and the wires in this section were broken.

• Brand Name: ROTATABLE SNARE
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 8911134
• MDR Text Key: 154901582
• Report Number: 3005099803-2019-04095
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729283980
• UDI-Public: 08714729283980
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160637
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: M00561821
• Device Catalogue Number: 6182
• Device Lot Number: 0023283589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2019
• 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