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  

Manufacturer Narrative

The complainant was unable to report the 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 medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a stone cone nitinol urological retrieval coil was used in the ureter during a lithotripsy procedure.According to the complainant, when the device was removed from the patient after the procedure, it was observed that the green/blue coating of the stone cone nitinol urological retrieval coil was "peeled/ untwisted".The procedure was successfully completed with this device.The physician stated that during lithotripsy, the probe of lithotripsy system might have had contact with stone cone nitinol urological retrieval coil and caused the damage, but is not sure.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 white heat shrink was accordioned and stretched at the proximal end.The blue/green heat shrink on the cone is peeling.Functional evaluation was performed and the device was stuck halfway and would not open nor close.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.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.

Event Description

It was reported to boston scientific corporation that a stone cone nitinol urological retrieval coil was used in the ureter during a lithotripsy procedure.According to the complainant, when the device was removed from the patient after the procedure, it was observed that the green/blue coating of the stone cone nitinol urological retrieval coil was "peeled/ untwisted".The procedure was successfully completed with this device.The physician stated that during lithotripsy, the probe of lithotripsy system might have had contact with stone cone nitinol urological retrieval coil and caused the damage, but is not sure.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: 5110339
• MDR Text Key: 26984384
• Report Number: 3005099803-2015-02748
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 09/03/2015

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: 09/30/2017
• Device Model Number: M0063903200
• Device Catalogue Number: 390-320
• Device Lot Number: D02491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2014
• 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