MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL; DISLODGER, STONE, FLEXIBLE

Model Number M0063903100

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/09/2015

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.However, the complainant reported that the device was not expired.(b)(4).The device has been received for analysis.Upon 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 urological retrieval coil was used during a ureteroscopy (urs) procedure in the ureter performed on (b)(6) 2015.According to the complainant, during the procedure, the distal tip of the coil detached.It was reported that no resistance was met when inserting the device into the channel of the scope.When the physician attempted to retract the coil back into the sheath, the coil got tangled.The physician withdrew the coil with force and after the device was removed, the distal tip of the coil detached outside of the patient.Additionally, no fragments fell inside the patient.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.

Manufacturer Narrative

A visual analysis of the returned device revealed that the distal end of the cone which includes the distal stop and ball is missing and was not returned.The remaining part of the cone would open freely but not completely due to the missing distal end.No melting was observed around the cone.Based on the condition of the returned device, the complaint was confirmed.Since the complaint is associated with a product which met specifications but most likely encountered anatomical or procedural factors which limited its performance, the most probable root cause for this event is operational context.

Event Description

It was reported to boston scientific corporation that a stone cone nitinol urological retrieval coil was used during a ureteroscopy (urs) procedure in the ureter performed on (b)(6) 2015.According to the complainant, during the procedure, the distal tip of the coil detached.It was reported that no resistance was met when inserting the device into the channel of the scope.When the physician attempted to retract the coil back into the sheath, the coil got tangled.The physician withdrew the coil with force and after the device was removed, the distal tip of the coil detached outside of the patient.Additionally, no fragments fell inside the patient.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.

• Brand Name: STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL
• Type of Device: DISLODGER, STONE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): ACCELLENT ENDOSCOPY JUAREZ; 31c butterfield trail; el paso TX 79906
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 5135073
• MDR Text Key: 28145929
• Report Number: 3005099803-2015-02858
• Device Sequence Number: 1
• Product Code: FGO
• 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,distri
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 09/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0063903100
• Device Catalogue Number: 390-310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2015
• 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