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 No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The exact age of the patient is unknown.However, it was reported the patient was over 18 years.(b)(4).The device has not been received for analysis.Upon receipt and 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.

Event Description

It was reported to boston scientific corporation that an uphold¿ lite device was used during an unknown procedure performed on (b)(6) 2017.According to complainant, during preparation, the needle detached from the suture.The procedure was completed with another uphold¿ lite 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.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.

Event Description

It was reported to boston scientific corporation that an uphold lite device was used during an unknown procedure performed on (b)(6) 2017.According to complainant, during preparation, the needle detached from the suture.The procedure was completed with another uphold lite 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.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.Additional information received on october 27, 2017.The procedure performed on (b)(6) 2017 was correction of pelvic prolapse.

Manufacturer Narrative

A visual examination of the returned uphold lite revealed that the suture on the blue with white stripe dilator is broken.The remainder of the suture with dart was not returned.The capio slim suture capturing device was not returned.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 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.

Event Description

It was reported to boston scientific corporation that an uphold lite device was used during an unknown procedure performed on (b)(6) 2017.According to complainant, during preparation, the needle detached from the suture.The procedure was completed with another uphold lite 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.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.Additional information received on october 27, 2017.The procedure performed on (b)(6) 2017 was correction of pelvic prolapse.

Manufacturer Narrative

The assigned complaint investigation conclusion code for this event is supplier manufacturing process design, and not manufacturing process design as previously reported, because the design or validation of the supplier manufacturing process was not sufficient to ensure the finished device met the intent of the design.

Event Description

It was reported to boston scientific corporation that an uphold lite device was used during an unknown procedure performed on (b)(6) 2017.According to complainant, during preparation, the needle detached from the suture.The procedure was completed with another uphold lite 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.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.Additional information received on october 27, 2017.The procedure performed on (b)(6) 2017 was correction of pelvic prolapse.

• 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: 6986643
• MDR Text Key: 91208436
• Report Number: 3005099803-2017-03114
• Device Sequence Number: 1
• Product Code: OTP
• UDI-Device Identifier: 08714729839200
• UDI-Public: 08714729839200
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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,Followup,Followup
• Report Date: 10/02/2017

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: 12/13/2019
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Device Lot Number: 0000051090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2017
• Initial Date FDA Received: 10/30/2017
• Supplement Dates Manufacturer Received: 10/27/2017; 05/09/2018; 07/19/2018
• Supplement Dates FDA Received: 11/21/2017; 06/04/2018; 07/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2017
• 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