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

Model Number	M0063801000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a segura hemisphere retrieval basket was used in the ureter during a ureterscopy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the basket broke inside the patient.There were no patient complications as a result of this event.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
Correction: device identification (model number).Device problem code 1069 captures the reportable event of basket wire broke.Investigation results: visual analysis found the returned device under good condition without evidence of damages or defects.The basket wires were not broken, all the basket wires were found to be properly attached to the pull wire.The investigation conclusion code of this event is "no problem detected" since the device complaint or problem cannot be confirmed.A review of the device history record (dhr) confirms that the accepted device met all manufacturing specifications.
Event or Problem Description
It was reported to boston scientific corporation that a segura hemisphere retrieval basket was used in the ureter during a ureterscopy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the basket broke inside the patient.There were no patient complications as a result of this event.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: SEGURA HEMISPHERE
• Common Device Name: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8564701
• Report Number: 3005099803-2019-02224
• Device Sequence Number: 11520655
• Product Code: FFL
• UDI-Device Identifier: 08714729341864
• UDI-Public: 08714729341864
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/28/2021
• Device Model Number: M0063801000
• Device Catalogue Number: 380-100
• Device Lot Number: 0023004315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Initial Date Received by Manufacturer: 04/03/2019
• Supplement Date Received by Manufacturer: 05/27/2019
• Initial Report FDA Received Date: 04/30/2019
• Supplement Report FDA Received Date: 06/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1