MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH SEGURA HEMISPHERE¿; DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number M0063801060

Device Problems Difficult to Remove (1528); Difficult to Open or Close (2921)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/06/2018

Event Type  malfunction  

Manufacturer Narrative

The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a segura hemisphere¿ stone retrieval basket was used in the ureter during a ureteroscopy with placement of a double j probe procedure performed on (b)(6) 2018.According to the complainant, during the procedure, when the segura basket was inserted into the ureter, a piece of the basket got stuck in the ureter.A laser fiber was used to cut the basket and remove it from the patient.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.

Manufacturer Narrative

(b)(6).

Event Description

It was reported to boston scientific corporation that a segura hemisphere stone retrieval basket was used in the ureter during a ureteroscopy with placement of a double j probe procedure performed on (b)(6) 2018.According to the complainant, during the procedure, when the segura basket was inserted into the ureter, a piece of the basket got stuck in the ureter.A laser fiber was used to cut the basket and remove it from the patient.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.

Event Description

It was reported to boston scientific corporation that a segura hemisphere stone retrieval basket was used in the ureter during a ureteroscopy with placement of a double j probe procedure performed on (b)(6) 2018.According to the complainant, during the procedure, when the segura basket was inserted into the ureter, a piece of the basket got stuck in the ureter.A laser fiber was used to cut the basket and remove it from the patient.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.Additional information received as of april 05, 2018.Basket failed to release the stone and was stuck inside the ureter.The procedure was completed with another segura basket.

• Brand Name: SEGURA HEMISPHERE¿
• Type of Device: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• 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: 7385076
• MDR Text Key: 103943376
• Report Number: 3005099803-2018-01042
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 08714729341901
• UDI-Public: 08714729341901
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup,Followup
• Report Date: 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/22/2020
• Device Model Number: M0063801060
• Device Catalogue Number: 380-106
• Device Lot Number: 20678705
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2018
• Initial Date FDA Received: 03/30/2018
• Supplement Dates Manufacturer Received: 03/08/2018; 04/05/2018
• Supplement Dates FDA Received: 04/04/2018; 04/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention