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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 Problem Detachment Of Device Component (1104)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 11/30/2016
Event Type  Injury  
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 (tm) lite w/ capio slim was used during sacrospinous ligament fixation procedure on (b)(6) 2016.According to the complainant, during the procedure, the needle detached while implanting the first leg.It was too small to be removed and was left inside the patient.The procedure was completed with another uphold (tm) 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
A visual examination of the returned uphold¿ lite revealed that the blue with white stripe dilator is broken.There is frayed suture remaining at the break.The suture and dart are missing and were not returned.Also, the analysis revealed no damage to the capio slim suture capturing device.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.The investigation concluded that this complaint is associated with a product that meets the design and manufacture specifications but due to anatomical/procedural factors encountered during the procedure, performance of the device was limited.The most probable root cause classification is operational context.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.
 
Event Description
It was reported to boston scientific corporation that an uphold (tm) lite w/ capio slim was used during sacrospinous ligament fixation procedure on (b)(6) 2016.According to the complainant, during the procedure, the needle detached while implanting the first leg.It was too small to be removed and was left inside the patient.The procedure was completed with another uphold (tm) 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 Key6214992
MDR Text Key63609239
Report Number3005099803-2016-03886
Device Sequence Number1
Product Code OTP
UDI-Device Identifier08714729839200
UDI-Public(01)08714729839200(17)20190215(10)ML00003494
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 12/02/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/15/2019
Device Model NumberM0068318170
Device Catalogue Number831-817
Device Lot NumberML00003494
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/08/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/02/2016
Initial Date FDA Received12/29/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/26/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/30/2016
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 Outcome(s) Other;
Patient Age60 YR
Patient Weight44
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