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

Model Number M0063903200

Device Problem Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a stone cone nitinol urological retrieval coil was used in the ureter during a procedure on an unknown date.According to the complainant, during the procedure and after the basket coil was retracted to and extended out of the sheath repeatedly, they noted that the blue and green coating became loose.No fragments of the coating fell inside the patient.The procedure was completed with this device.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

The complainant was unable to report the device lot number; therefore, the manufacture date and expiration date are unknown.However, the complainant stated that the device was used prior to the expiration date.Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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.

Manufacturer Narrative

Additional information: a visual analysis of the returned stone cone nitinol urological retrieval coil revealed that the blue and green shrink was accordion near the distal ro marker.Additionally, the blue sheath was kinked in two places on the proximal end of the blue sheath.A tool mark on the white heat shrink was also noted from the proximal end of the blue sheath.The distal stop was pulled inside the distal end of the blue sheath causing the device not to open or close.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.The device history record (dhr) review found that the device met all manufacturing specifications.

Event Description

It was reported to boston scientific corporation that a stone cone nitinol urological retrieval coil was used in the ureter during a procedure on an unknown date.According to the complainant, during the procedure and after the basket coil was retracted to and extended out of the sheath repeatedly, they noted that the blue and green coating became loose.No fragments of the coating fell inside the patient.The procedure was completed with this device.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: 4763393
• MDR Text Key: 5954556
• Report Number: 3005099803-2015-01326
• 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: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/14/2015

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: 08/31/2017
• Device Model Number: M0063903200
• Device Catalogue Number: 390-320
• Device Lot Number: C88385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2015
• Initial Date FDA Received: 05/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2014
• 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