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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OBTRYX SYSTEM - HALO; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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BOSTON SCIENTIFIC CORPORATION OBTRYX SYSTEM - HALO; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR Back to Search Results
Model Number M0068505000
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/08/2023
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that an obtryx system - halo was used into the patient during an obtryx procedure performed on (b)(6) 2023.During preparation, the surgeon found a foreign object in the device packaging.The sterile seal was noted to be intact, and no physical damaged was noted on the packaging.The procedure was completed with another obtryx system - halo.There were no patient complications as a result of the event.
 
Manufacturer Narrative
Imdrf device code a1802 captures the reportable event of foreign matter in the device packaging.
 
Event Description
It was reported to boston scientific corporation that an obtryx system - halo was opened and intended to be used during an obtryx procedure performed on (b)(6) 2023.During preparation, the surgeon found a foreign object in the device packaging.The sterile seal was noted to be intact, and no physical damaged was noted on the packaging.The procedure was completed with another obtryx system - halo.There were no patient complications as a result of the event.
 
Manufacturer Narrative
Correction to block b5.The device was not used on the patient.Block h6: imdrf device code a1802 captures the reportable event of foreign matter in the device packaging.
 
Manufacturer Narrative
Block h6: imdrf device code a1802 captures the reportable event of foreign matter in the device packaging.Block h10: the returned obtryx halo single system was analyzed, and visual inspection of the mesh assembly and the delivery devices did not identify any issues and were in good condition.The packaging was not received, however; images provided by the customer did not show any foreign material.With all the available information, boston scientific concludes that the reported complaint of foreign material in the device packaging is not confirmed.Additionally, the analysis of the device did not find any defect and the images provided by the customer did not show any foreign material.Based on the analyzed condition of the device, the complaint assigned an investigation conclusion code of "no problem detected" which indicates "the device complaint or problem cannot be confirmed.".
 
Event Description
It was reported to boston scientific corporation that an obtryx system - halo was opened and intended to be used during an obtryx procedure performed on (b)(6) 2023.During preparation, the surgeon found a foreign object in the device packaging.The sterile seal was noted to be intact, and no physical damaged was noted on the packaging.The procedure was completed with another obtryx system - halo.There were no patient complications as a result of the event.Please see block h10 for full investigation details.
 
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Brand Name
OBTRYX SYSTEM - HALO
Type of Device
MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
780 brookside drive
spencer IN 47460
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key16728788
MDR Text Key313200940
Report Number3005099803-2023-01991
Device Sequence Number1
Product Code OTN
UDI-Device Identifier08714729718987
UDI-Public08714729718987
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K040787
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 05/25/2023
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 Model NumberM0068505000
Device Catalogue Number850-500
Device Lot Number0029512322
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/05/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/15/2023
Initial Date FDA Received04/12/2023
Supplement Dates Manufacturer Received04/13/2023
05/03/2023
Supplement Dates FDA Received05/10/2023
05/25/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age55 YR
Patient SexFemale
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