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

Model Number M0063903200

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/25/2016

Event Type  Injury  

Manufacturer Narrative

(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 transurethral ureterolithotripsy (tul) procedure performed on (b)(6) 2016.According to the complainant, during the procedure, the distal tip of the device was detached upon withdrawal and was left in the ureter.The detached piece was retrieved using forceps.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

Visual analysis of the returned device found that the device was returned with the blue sheath removed.The cone was found broken and detached from the device.A scorch mark was noted at the break.Review and analysis of all available information indicates that the device damage was caused by the laser during ureteroscopy with laser lithotripsy procedure.Therefore, the most probable root cause is "caused by other device".The device history record (dhr) review found the device met all manufacturing specifications.A search of the complaint database revealed that no similar complaints exist for the specified lot.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 transurethral ureterolithotripsy (tul) procedure performed on (b)(6) 2016.According to the complainant, during the procedure, the distal tip of the device was detached upon withdrawal and was left in the ureter.The detached piece was retrieved using forceps.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: 5883835
• MDR Text Key: 52347074
• Report Number: 3005099803-2016-02421
• 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: Initial,Followup
• Report Date: 07/29/2016

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 Expiration Date: 10/07/2018
• Device Model Number: M0063903200
• Device Catalogue Number: 390-320
• Device Lot Number: E55373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/29/2016
• Initial Date FDA Received: 08/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2015
• 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): Required Intervention