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 Foreign Body In Patient (2687)

Event Date 01/12/2016

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 vaginal support system device was used during a sacrospinous ligament fixation procedure performed on (b)(6) 2016.According to the complainant, during the procedure and inside the patient, the needle detached and was not retrieved.The procedure was completed using another uphold vaginal support system device.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

Visual analysis of the returned uphold vaginal support system revealed that there was blood residue on the mesh assembly.The blue with white stripe dilator was broken into two pieces.The first piece was still attached to the mesh assembly while the second piece was detached which includes the suture and dart.The dilator was accordioned.The suture and dart are still attached to the blue dilator without damage noted.Functional analysis showed no damage on the capturing 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.  a search of the complaint database confirmed that no similar complaints exist for the specified batch.The returned device showed no evidence of either the alleged issue or any defect which could have contributed to the event.Therefore, the most probable root cause classification is not confirmed.

Event Description

It was reported to boston scientific corporation that an uphold vaginal support system device was used during a sacrospinous ligament fixation procedure performed on (b)(6) 2016.According to the complainant, during the procedure and inside the patient, the needle detached and was not retrieved.The procedure was completed using another uphold vaginal support system device.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: 5417919
• MDR Text Key: 37717077
• Report Number: 3005099803-2016-00144
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/12/2016

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: Physician
• Device Expiration Date: 09/01/2018
• Device Model Number: M0068317080
• Device Catalogue Number: 831-708
• Device Lot Number: ML00003166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2016
• Initial Date FDA Received: 02/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/07/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/28/2015
• 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: 54 YR
• Patient Weight: 48