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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 Consequences Or Impact To Patient (2199)
Event Date 01/09/2019
Event Type  malfunction  
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 medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that an obtryx system - halo device was used during a urinary incontinence procedure performed on (b)(6) 2019.According to the complainant, they found a foreign body upon opening the device package.Reportedly, the device was not used and had no contact with the patient.The procedure was completed with another obtryx system - halo device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
 
Manufacturer Narrative
Blocks f10 and h6: problem code 2969 captures the reportable event of foreign matter.Block h10: an examination of the returned mesh assembly and two halo delivery systems were performed.For the mesh assembly, the mesh, sleeves, dilators, association loops, and centering tab all appeared to be intact.No residue or debris were noted on the mesh assembly.For the returned delivery devices, no issues were found.The association loops were able to be loaded on and removed with no issues.Analysis found that the mesh assembly and delivery had no evidence of foreign matter.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.Analysis found the mesh assembly and delivery had no evidence of foreign matter.The condition of the device did not confirm the reported event.Based on the condition of the returned device, the reported event is assigned a cause of no problem detected, which indicates that the device complaint or problem cannot be confirmed.
 
Event Description
It was reported to boston scientific corporation that an obtryx system - halo device was used during a urinary incontinence procedure performed on (b)(6) 2019.According to the complainant, they found a foreign body upon opening the device package.Reportedly, the device was not used and had no contact with the patient.The procedure was completed with another obtryx system - halo device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
 
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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
MDR Report Key8338023
MDR Text Key136133661
Report Number3005099803-2019-00696
Device Sequence Number1
Product Code OTN
UDI-Device Identifier08714729718987
UDI-Public08714729718987
Combination Product (y/n)N
PMA/PMN Number
K040787
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/16/2019
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
Device Operator Health Professional
Device Expiration Date06/21/2021
Device Model NumberM0068505000
Device Catalogue Number850-500
Device Lot Number0022287525
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/11/2019
Initial Date Manufacturer Received 01/16/2019
Initial Date FDA Received02/13/2019
Supplement Dates Manufacturer Received06/18/2019
Supplement Dates FDA Received07/16/2019
Patient Sequence Number1
Patient Age68 YR
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