MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH UPHOLD? LITE; MESH, SURGICAL, SYNTHETIC

Model Number M0068318170

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/24/2014

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an uphold lite with capio slim were used during an anterior repair cystocele colporrhaphy procedure performed on (b)(6) 2014.According to the complainant, during preparation of the device while outside the patient, the suture broke from the needle.Another uphold lite and capio slim were used to finish the procedure.There were no patient complications reported as a result of this event.

Manufacturer Narrative

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.(b)(4).

Manufacturer Narrative

Analysis of the returned uphold lite w/ capio slim revealed that the leader loops, sleeves, and mesh body were intact and undamaged.The suture of the blue with white stripe dilator broke at approximately 1cm.Distal to the dilator and was frayed at both ends of the break point.There was evidence of fraying/tearing of the blue dilator at the distal, most narrow end.The blue dilator, suture and dart were attached to the mesh assembly.There was no visible damage to the capio suturing device.The suture throwing portion was intact and functional.A review of the device history record (dhr) was performed; no anomalies were noted.The most probable root cause classification is handling damage.

Event Description

It was reported to boston scientific corporation that an uphold lite with capio slim were used during an anterior repair cystocele colporrhaphy procedure performed on (b)(6) 2014.According to the complainant, during preparation of the device while outside the patient, the suture broke from the needle.Another uphold lite and capio slim were used to finish the procedure.There were no patient complications reported as a result of this event.

• Brand Name: UPHOLD? LITE
• 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: 4355349
• MDR Text Key: 5220470
• Report Number: 3005099803-2014-03976
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/24/2014

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: Physician
• Device Expiration Date: 05/31/2017
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Device Lot Number: ML00002350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2015
• Initial Date FDA Received: 12/23/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2014
• 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 Age: 53 YR