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

Model Number	M0063801020
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Although the suspect device has been received for analysis, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 basket was used in the ureter during a ureteroscopy procedure performed on (b)(6) 2019.According to the complainant, the distal part of the sheath of the basket was found to be torn.The procedure was completed with another segura hemi basket.There were serious injury nor any adverse patient effects reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
Additional Manufacturer Narrative
(b)(4).A segura basket was returned for analysis.Visual inspection found the tip of the basket assembly does not have any visual damage.The distal section of the sheath (tip area of the sheath) was torn/split, exposing the basket wires.It is most likely that handling and manipulation of the device during unpacking/prepping/procedure could have contributed with the reported issue.Therefore, based on the information available and the analysis performed, the investigation conclusion code is adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on event.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.
Event or Problem Description
It was reported to boston scientific corporation that a segura hemisphere basket was used in the ureter during a ureteroscopy procedure performed on (b)(6) 2019.According to the complainant, the distal part of the sheath of the basket was found to be torn.The procedure was completed with another segura hemi basket.There were serious injury nor any adverse patient effects reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

• 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: 8450190
• Report Number: 3005099803-2019-01440
• Device Sequence Number: 2978492
• Product Code: FFL
• UDI-Device Identifier: 08714729341888
• UDI-Public: 08714729341888
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/18/2019

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: 10/12/2021
• Device Model Number: M0063801020
• Device Catalogue Number: 380-102
• Device Lot Number: 0022788879
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2019
• Initial Date Received by Manufacturer: 03/01/2019
• Supplement Date Received by Manufacturer: 03/28/2019
• Initial Report FDA Received Date: 03/25/2019
• Supplement Report FDA Received Date: 04/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR