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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER UPHOLD¿ LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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BOSTON SCIENTIFIC - SPENCER 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 No Consequences Or Impact To Patient (2199)
Event Date 04/25/2018
Event Type  Injury  
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 uphold¿ lite with capio slim was implanted during an anterior cystocele repair with cystoscopy procedure performed on (b)(6) 2018.According to the complainant, during the procedure, when they cut the suture, the sleeve won¿t come off.The physician proceeded with the procedure and while implanting the device, a piece of suture detached and was inside the patient.Reportedly, they found the detached suture and removed it.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 fine.
 
Manufacturer Narrative
A visual examination of the returned uphold¿ lite with capio slim revealed that only two dilators and part of a suture were returned.The suture on the blue with white stripe dilator was cut.The remainder of the suture with dart was not returned.The user most likely cut the suture to facilitate removal.The suture on the blue dilator was broken.The remainder of the suture with dart was not returned.The capio slim suture capturing device was not returned.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¿ lite with capio slim was implanted during an anterior cystocele repair with cystoscopy procedure performed on (b)(6) 2018.According to the complainant, during the procedure, when they cut the suture, the sleeve won¿t come off.The physician proceeded with the procedure and while implanting the device, a piece of suture detached and was inside the patient.Reportedly, they found the detached suture and removed it.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 fine.
 
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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 - SPENCER
780 brookside drive
spencer IN 47460
MDR Report Key7535089
MDR Text Key108976586
Report Number3005099803-2018-01514
Device Sequence Number1
Product Code OTP
UDI-Device Identifier08714729839200
UDI-Public08714729839200
Combination Product (y/n)N
PMA/PMN Number
K122459
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 04/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/16/2020
Device Model NumberM0068318170
Device Catalogue Number831-817
Device Lot Number21402115
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/04/2018
Date Manufacturer Received06/29/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age83 YR
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