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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH UPHOLD¿ LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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BOSTON SCIENTIFIC - MARLBOROUGH UPHOLD¿ LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN Back to Search Results
Model Number M0068318170
Device Problems Break (1069); Retraction Problem (1536); Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/26/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has been received for analysis.Upon 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 uphold lite w/ capio slim was used during a sacrospinous ligament fixation procedure performed on (b)(6) 2016.According to the complainant, during the procedure and inside the patient, the body of the mesh split into two pieces.All of the components of the device have been removed from the patient using a pair of forceps.The procedure was completed with another uphold lite w/ capio slim.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
(b)(4) suture broken.(b)(4) carrier would not retract.Although the full investigation did not confirm that the reported event of mesh split into two pieces, operational problem is being used to capture the investigation results of lead suture broken and capio suture capturing device carrier retracted slowly.Analysis of the returned uphold (tm) lite w/ capio slim device did not confirm the event.Visual inspection of the mesh assembly revealed no damage.The suture on the blue dilator was broken and frayed.The dart was missing and was not returned.The blue dilator was bunched and torn.Visual and functional examination of the capio suture capturing device revealed that the carrier retracted slowly.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. a search of the complaint database confirmed that one similar complaint exists for the specified batch.The returned device showed no evidence of either the alleged issue or any defect which could have contributed to the event.Therefore, the most probable root cause classification is not confirmed.
 
Event Description
It was reported to boston scientific corporation that an uphold lite w/ capio slim was used during a sacrospinous ligament fixation procedure performed on (b)(6) 2016.According to the complainant, during the procedure and inside the patient, the body of the mesh split into two pieces.All of the components of the device have been removed from the patient using a pair of forceps.The procedure was completed with another uphold lite w/ capio slim.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
UPHOLD¿ LITE
Type of Device
MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
Manufacturer (Section D)
BOSTON SCIENTIFIC - MARLBOROUGH
100 boston scientific way
marlborough MA 01752
Manufacturer Contact
nancy cutino
100 boston scientific way
marlborough, MA 01752
5086834000
MDR Report Key5669765
MDR Text Key45627894
Report Number3005099803-2016-01389
Device Sequence Number1
Product Code OTP
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K122459
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/26/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/26/2018
Device Model NumberM0068318170
Device Catalogue Number831-817
Device Lot NumberML00003266
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/06/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/08/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/18/2015
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 Age63 YR
Patient Weight65
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