MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UPHOLD LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN

Model Number M0068318170

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).The complainant indicated that the device is not expected to be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an uphold lite with capio slim device was implanted during a cystocele repair procedure performed on (b)(6) 2018.According to the complainant, the capio carrier did not retract after the dart was caught in the capio cage.Reportedly, the problem occurred outside the patient after the procedure.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block e1: additional fax number: (b)(6).Blocks f10 and h6: problem code of 1536 for captures the reportable event of carrier retraction problem.Block g1: manufacturing site although the current manufacturing site for uphold lite is boston scientific in spencer in, the reported lot involved in this complaint was manufactured by: freudenberg medical, 2301 centennial boulevard, jefferson in, 47130 usa.Block h10: the complainant indicated that the device is implanted and will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an uphold lite with capio slim device was implanted during a cystocele repair procedure performed on (b)(6) 2018.According to the complainant, the capio carrier did not retract after the dart was caught in the capio cage.Reportedly, the problem occurred outside the patient after it was used in the procedure.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: UPHOLD LITE
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8223433
• MDR Text Key: 132277626
• Report Number: 3005099803-2018-62448
• Device Sequence Number: 1
• Product Code: OTP
• UDI-Device Identifier: 08714729839200
• UDI-Public: 08714729839200
• Combination Product (y/n): N
• PMA/PMN Number: K122459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/31/2019

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 Date: 04/22/2019
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Device Lot Number: 0000028974
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/10/2018
• Initial Date FDA Received: 01/07/2019
• Supplement Dates Manufacturer Received: 01/14/2019
• Supplement Dates FDA Received: 01/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1