MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH UPHOLD VAGINAL SUPPORT SYSTEM; MESH, SURGICAL, SYNTHETIC

Model Number M0068317080

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2014

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an uphold vaginal support system was used during a sacrospinous ligament fixation procedure performed on (b)(6), 2014.According to the complainant, during the procedure, the needle detached while the physician was pulling the suture through the tissue.The needle was not retrieved.The procedure was completed with another uphold vaginal support system.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): although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Manufacturer Narrative

Analysis of the returned uphold vaginal support system revealed that there was blood residue on the mesh body.The blue dilator was broken and measured 2.0 cm.The suture and dart were not returned.The suture on the blue with white striped dilator was frayed.There was no damage to the capio 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.

Event Description

It was reported to boston scientific corporation that an uphold vaginal support system was used during a sacrospinous ligament fixation procedure performed on (b)(6) 2014.According to the complainant, during the procedure, the needle detached while the physician was pulling the suture through the tissue.The needle was not retrieved.The procedure was completed with another uphold vaginal support system.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.

• Brand Name: UPHOLD VAGINAL SUPPORT SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): MEDVENTURE TECHNOLOGY CORPORATION; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 4359031
• MDR Text Key: 5204848
• Report Number: 3005099803-2014-04030
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K081048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/02/2014

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 Date: 03/31/2017
• Device Model Number: M0068317080
• Device Catalogue Number: 831-708
• Device Lot Number: ML00002167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2015
• Initial Date FDA Received: 12/23/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2014
• 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: 48 YR
• Patient Weight: 58