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

Model Number M0063901050

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 07/09/2015

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a zero tip¿ stone retrieval basket was used in the ureter during a fiberoptic transurethral nephrolithotripsy procedure performed on (b)(6) 2015.According to the complainant, during the procedure, an attempt to remove the stone was performed.However, the device got stuck in the upper ureter and the wire detached inside the patient.Hence, the procedure was not completed.It was also reported that the patient had damage to the ureter.Despite numerous attempts boston scientific has been unable obtain additional information regarding the circumstances surrounding this event.Should additional relevant details become available a supplemental report will be submitted.

Manufacturer Narrative

Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.The complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.However, the complainant stated that the device was used prior to the expiration date.Reported event of ¿wire detached inside the patient.¿ 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 ureter during a fiberoptic transurethral nephrolithotripsy procedure performed on (b)(6) 2015.According to the complainant, during the procedure, an attempt to remove the stone was performed.However, the device got stuck in the upper ureter and the wire detached inside the patient.Hence, the procedure was not completed.It was also reported that the patient had damage to the ureter.Despite numerous attempts boston scientific has been unable obtain additional information regarding the circumstances surrounding this event.Should additional relevant details become available a supplemental report will be submitted.Additional information received as of august 10, 2015.The patient¿s ureter was perforated during the procedure.Surgery was performed to remove the detached piece of the basket wire, and to repair the ureter.The damaged vessel of the ureter was cut and inosculated by the physician.The patient 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: 4966138
• MDR Text Key: 6640482
• Report Number: 3005099803-2015-02217
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,company represent
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0063901050
• Device Catalogue Number: 390-105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Required Intervention
• Patient Age: 65 YR