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

Model Number M0063901010

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/02/2018

Event Type  malfunction  

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 zero tip¿ stone retrieval basket was used in a flexible ureterorenoscopy (furs) procedure performed on (b)(6) 2018.According to the complainant, during unpacking, it was noted that there was no basket.The procedure was completed with another zero tip¿ stone retrieval basket.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 - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7361292
• MDR Text Key: 103302342
• Report Number: 3005099803-2018-00931
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 08714729342007
• UDI-Public: 08714729342007
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2021
• Device Model Number: M0063901010
• Device Catalogue Number: 390-101
• Device Lot Number: 21710446
• 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: 02/06/2018
• 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