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

Model Number M0063901050

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/02/2018

Event Type  Injury  

Manufacturer Narrative

The complainant indicated that the device remains inside the patient and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is available or if the device is available at a later date, 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 urethra, during a stone removal procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the basket was inserted to capture a stone.The basket was opened and closed while the stone was still inside and in an attempt to remove the stone, the basket cage broke off inside the patient.Only the catheter was removed successfully.Attempts to remove the basket cage and stone were performed; however, they were not successful.The physician left the basket and stone inside the patient, with plans for removal by lithotripsy to be performed on a later date.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.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available; a supplemental report will be submitted.

• 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: 7361304
• MDR Text Key: 103156281
• Report Number: 3005099803-2018-00821
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 08714729469643
• UDI-Public: 08714729469643
• 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: 03/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2020
• Device Model Number: M0063901050
• Device Catalogue Number: 390-105
• Device Lot Number: 21700663
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2018
• 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 Age: 89 YR