MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER GEMINI¿; DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number M0063301070

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a gemini¿ basket was used in the ureter during a ureteroscopy procedure, performed on (b)(6) of 2017.According to the complainant, post procedure, the patient came back with a complaint of pain.The patient underwent surgery on (b)(6) 2018 and a yellow plastic sheath that was identified to be a part of a gemini¿ basket was found inside the ureter.The sheath of the basket was removed, and a stent was placed in the patient to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the surgery was reported to be fine.

• Brand Name: GEMINI¿
• Type of Device: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer (Section G): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7278090
• MDR Text Key: 100309221
• Report Number: 3005099803-2018-00435
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 08714729057031
• UDI-Public: 08714729057031
• 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
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/15/2020
• Device Model Number: M0063301070
• Device Catalogue Number: 330-107
• Device Lot Number: 0021015429
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2017
• 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: 51 YR
• Patient Weight: 94