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

Model Number M0063903100

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

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 stated that the device was used prior to the expiration date.(b)(6).Medwatch# 5063754.The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, 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 cystourethroscopy and ureteroscopy (urs) with laser lithotripsy procedure performed on (b)(6) 2015, at an unknown hospital.According to the complainant, during the procedure, the distal part of the device detached in the patient's right ureter.The detachment was not initially discovered, and there were no patient complications reported.Approximately 2 weeks post-procedure, the patient stated that "an umbrella like device which appeared to be made of cellophane passed through his urethra".Ct scan revealed that a foreign body was noted to be in the right ureter.The foreign body was unable to be removed ureteroscopically, thus surgical intervention was required.It was not documented that the device came into contact with the laser during the procedure, but according to the complainant that is the assumption.On (b)(6) 2016, at (b)(6) mc, during a right antegrade ureteroscopy with stent placement procedure, two mildly encrusted fragments of stone cone nitinol urological retrieval coil device were retrieved.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

Visual analysis of the returned device found that retrieval coil was detached/ separated and only approximately 5.5 cm of the distal end was returned.The returned piece is the distal end of the coil including the distal stop and ball weld.Review and analysis of all available information indicates that the device damage was caused by encountered anatomical or procedural factors which limits its performance.Therefore, the most probable root cause is "operational context".A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label. .

Event Description

It was reported to boston scientific corporation that a stone cone nitinol urological retrieval coil was used during a cystourethroscopy and ureteroscopy (urs) with laser lithotripsy procedure performed on (b)(6) 2015, at an unknown hospital.According to the complainant, during the procedure, the distal part of the device detached in the patients right ureter.The detachment was not initially discovered, and there were no patient complications reported.Approximately 2 weeks post-procedure, the patient stated that "an umbrella like device which appeared to be made of cellophane passed through his urethra." ct scan revealed that a foreign body was noted to be in the right ureter.The foreign body was unable to be removed ureteroscopically, thus surgical intervention was required.It was not documented that the device came into contact with the laser during the procedure, but according to the complainant that is the assumption.On (b)(6) 2016, at richmond vamc, during a right antegrade ureteroscopy with stent placement procedure, two mildly encrusted fragments of stone cone nitinol urological retrieval coil device were retrieved.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: 5959181
• MDR Text Key: 54992191
• Report Number: 3005099803-2016-02629
• Device Sequence Number: 1
• Product Code: FGO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 10/06/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2016
• Initial Date FDA Received: 09/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/15/2016
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 118