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

Model Number M0063801060

Device Problems Break (1069); Difficult to Open or Close (2921); Material Deformation (2976); Material Twisted/Bent (2981)

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

Event Date 06/06/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Visual inspection found the basket was received opened.Additionally, the sheath was found detached/separated in the proximal and distal section of the device.One portion of the distal sheath was not returned for analysis.A kink was found in the proximal section of the sheath and the basket wires were bent/kink.Functional inspection found the basket could not be extended probably due to the section of the sheath that was detached/separated.The failures found (sheath detached/separated, sheath kinked, and basket wires bent/kinked) are issues that could have been generated by the user during manipulation or handling of the product.Once the sheath has been damaged, the basket section cannot be extended or retracted properly.Therefore, based on all available information, the most probable root cause is unintended user error caused or contributed to event since the interaction between the user and device, or sample, caused or contributed to the error.This includes the unintended inappropriate use of the device and incorrect sample preparation.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.Labeling review was performed and found no evidence that the device was not used in accordance with the directions for use/label.

Event Description

It was reported to boston scientific corporation that a segura hemisphere retrieval basket was used in a procedure on (b)(6) 2019.According to the complainant, the segura hemisphere basket malfunctioned.Another segura hemisphere basket was used to complete the procedure.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.This event has been deemed a reportable event based on the investigation results revealing the sheath was torn at distal end.

Manufacturer Narrative

Block h6: device code 1069 captures the reportable investigation result of sheath detached/separated.Block h10: visual inspection found the basket was received opened.Additionally, the sheath was found detached/separated in the proximal and distal section of the device.One portion of the distal sheath was not returned for analysis.A kink was found in the proximal section of the sheath and the basket wires were bent/kink.Functional inspection found the basket could not be extended probably due to the section of the sheath that was detached/separated.The failures found are issues that could have been generated by the user during manipulation or handling of the product.Once the sheath has been damaged, the basket section cannot be extended or retracted properly.During the manufacturing process, the device is inspected to ensure it meets specifications.However, there is no control how the devices are handled or manipulated in the field.Therefore, based on all available information, the most probable root cause is adverse event related to procedure.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.Block h11: correction: h6 (evaluation conclusion codes), h10 (additional mfr narrative).

Event Description

It was reported to boston scientific corporation that a segura hemisphere retrieval basket was used in a procedure on (b)(6) 2019.According to the complainant, the segura hemisphere basket malfunctioned.Another segura hemisphere basket was used to complete the procedure.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.This event has been deemed a reportable event based on the investigation results revealing the sheath was torn at distal end.Please see block h10 for full investigation details.

• Brand Name: SEGURA HEMISPHERE
• Type of Device: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9174731
• MDR Text Key: 161808913
• Report Number: 3005099803-2019-04941
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 08714729341901
• UDI-Public: 08714729341901
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/14/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2021
• Device Model Number: M0063801060
• Device Catalogue Number: 380-106
• Device Lot Number: 0023070756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2019
• Initial Date Manufacturer Received: 09/19/2019
• Initial Date FDA Received: 10/10/2019
• Supplement Dates Manufacturer Received: 01/21/2020
• Supplement Dates FDA Received: 02/14/2020
• Patient Sequence Number: 1
• Patient Age: 83 YR