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

Model Number M0068318170

Device Problem Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/11/2018

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 device was used during a sacrospinous ligament fixation procedure performed on (b)(6) 2018 according to the complainant, during the procedure, the needle detached on the left side of the patient while implanting the first leg.Reportedly, it was too small to be removed and was left inside the patient.The procedure was completed with another uphold¿ lite w/ capio slim.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 and capio slim revealed that the suture on the blue dilator is broken.The remainder of the suture with dart was not returned.There is no damage to the 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.Analysis reveals that the suture is severed, which could be due to interaction with the sharp edge of the carrier.Therefore, the assigned complaint investigation conclusion code for this event is manufacturing process design because the design or validation of the manufacturing process was not sufficient to ensure the finished device met the intent of the design.The issue is under investigation and a correction has not yet been implemented.

Event Description

It was reported to boston scientific corporation that an uphold (tm) lite with capio slim device was used during a sacrospinous ligament fixation procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the needle detached on the left side of the patient while implanting the first leg.Reportedly, it was too small to be removed and was left inside the patient.The procedure was completed with another uphold lite with capio slim.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 - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7243297
• MDR Text Key: 99069846
• Report Number: 3005099803-2018-00171
• Device Sequence Number: 1
• Product Code: OTP
• UDI-Device Identifier: 08714729839200
• UDI-Public: 08714729839200
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K122459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2020
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Device Lot Number: 0000058945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Weight: 51