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 Consequences Or Impact To Patient (2199)

Event Date 03/10/2016

Event Type  Injury  

Manufacturer Narrative

The exact patient age is unknown; however, is reported to be over 18 years old.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 with laser lithotripsy procedure performed on (b)(6) 2016.According to the complainant, during the procedure, the coil detached into the patient.The physician stated that he ¿may have hit the stone cone while trying to laser the stone¿.The physician removed the stone and retrieved the coil of the device using a tricep grasper.The procedure was completed with the tricep grasper.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 fine.

Manufacturer Narrative

A visual analysis of the returned device revealed that only part of the coil with the distal stop and ball weld was returned.There is a burn mark on the blue green shrink indicating that the device was scorched.Since the device shows evidence of scorching which was most likely caused by the laser during the ureteroscopy with laser lithotripsy procedure, the most probable root cause for this complaint event is caused by other device.A search of the complaint database revealed that no similar complaints exist for the specified lot.The device history record (dhr) review found the device met all manufacturing specifications.A labeling review was performed and no anomaly was found.

Event Description

It was reported to boston scientific corporation that a stone cone nitinol urological retrieval coil was used during a ureteroscopy with laser lithotripsy procedure performed on (b)(6) 2016.According to the complainant, during the procedure, the coil detached into the patient.The physician stated that he "may have hit the stone cone while trying to laser the stone".The physician removed the stone and retrieved the coil of the device using a tricep grasper.The procedure was completed with the tricep grasper.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 fine.

• 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: 5537115
• MDR Text Key: 41516861
• Report Number: 3005099803-2016-00775
• 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: 03/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2018
• Device Model Number: M0063903100
• Device Catalogue Number: 390-310
• Device Lot Number: E33766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2015
• 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): Other