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

Model Number	M0063801060
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/06/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 Manufacturer Narrative
(b)(6).
Event or Problem 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 or Problem 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¿
• Common Device Name: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 7385076
• Report Number: 3005099803-2018-01042
• Device Sequence Number: 11020460
• Product Code: FFL
• UDI-Device Identifier: 08714729341901
• UDI-Public: 08714729341901
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 03/08/2018
• Supplement Date Received by Manufacturer: 03/08/2018; 04/05/2018
• Initial Report FDA Received Date: 03/30/2018
• Supplement Report FDA Received Date: 04/04/2018; 04/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention