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

Model Number	M0063801070
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/18/2020
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 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 cystoscopy left ureteroscopy stone manipulation laser lithotripsy bladder biopsy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the physician noticed a crack and an orange sheet when he deployed the basket.The basket was removed and under direct visualization, the device was found intact.The physician went back to make sure that nothing left behind.No patient complications have been reported as a result of the event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Event or Problem Description
It was reported to boston scientific corporation that a segura hemisphere basket was used in the ureter during a cystoscopy left ureteroscopy stone manipulation laser lithotripsy bladder biopsy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the physician noticed a crack and an orange sheet when he deployed the basket.The basket was removed and under direct visualization, the device was found intact.The physician went back to make sure that nothing left behind.No patient complications have been reported as a result of the event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Additional Manufacturer Narrative
Block h6: device code 4008 captures the reported event of "crack and an orange sheet when deployed the basket".Block h10: visual analysis found the basket was open when received.The sheath was found torn at the distal section.Additionally, kinks were observed on the sheath and one of the basket wires is bent/kinked.Functional inspection was performed and found the basket could not be extended/retracted when the handle was actuated, probably due to the torn sheath.Based on all available information, the failures found could have been generated by the user during manipulation/handling of the product.Once the sheath has been damaged, it will affect the functionality of the device since this type of defects do not allow the device to perform its function to move backward/forward as expected; hence, the basket section cannot be extended or retracted properly.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.

• 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: 9722975
• Report Number: 3005099803-2020-00498
• Device Sequence Number: 19421311
• Product Code: FFL
• UDI-Device Identifier: 08714729341918
• UDI-Public: 08714729341918
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 04/13/2020

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: 03/07/2022
• Device Model Number: M0063801070
• Device Catalogue Number: 380-107
• Device Lot Number: 0023457137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Initial Date Received by Manufacturer: 01/21/2020
• Supplement Date Received by Manufacturer: 03/16/2020
• Initial Report FDA Received Date: 02/18/2020
• Supplement Report FDA Received Date: 04/13/2020
• Patient Sequence Number: 1