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

Model Number M0063901050

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/26/2017

Event Type  malfunction  

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over the age of 18.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 zero tip¿ stone retrieval basket was used in the kidney during a flexible ureterorenoscopy procedure performed on (b)(6) 2017.According to the complainant, during the procedure, a zero tip basket was placed to capture a stone.An attempt to remove the basket from the patient was made but was unsuccessful and the basket could not be removed.A laser was then used to cut the basket wire to release the stone from the basket.The basket and the stone was successfully removed from the patient.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 stable.

• Brand Name: ZERO TIP¿
• 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: 7008617
• MDR Text Key: 92500914
• Report Number: 3005099803-2017-03287
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 08714729469643
• UDI-Public: 08714729469643
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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
• Report Date: 10/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: M0063901050
• Device Catalogue Number: 390-105
• Device Lot Number: 19219420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2016
• 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