• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION SEGURA HEMISPHERE; DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key9174731
MDR Text Key161808913
Report Number3005099803-2019-04941
Device Sequence Number1
Product Code FFL
UDI-Device Identifier08714729341901
UDI-Public08714729341901
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
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 Date12/11/2021
Device Model NumberM0063801060
Device Catalogue Number380-106
Device Lot Number0023070756
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/23/2019
Initial Date Manufacturer Received 09/19/2019
Initial Date FDA Received10/10/2019
Supplement Dates Manufacturer Received01/21/2020
Supplement Dates FDA Received02/14/2020
Patient Sequence Number1
Patient Age83 YR
-
-