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

Model Number M0068318170

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2017

Event Type  malfunction  

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 mdr will be filed.

Event Description

It was reported to boston scientific corporation that an uphold¿ lite device was used during a sacrospinous ligament fixation procedure performed on (b)(6) 2017.According to the complainant, during procedure, when the physician tried to put the needle into the capio cage outside the patient, the lead suture near the dilator broke.The procedure was completed with another uphold¿ lite device.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Analysis of the returned uphold¿ lite revealed that the blue dilator was returned with its distal end torn off.The analysis revealed that the blue dilator was returned with approximately 5.0 cm of the distal end torn off.The remainder of the dilator assembly including the suture and dart was not returned.Analysis also revealed that the carrier on the capio slim suture capturing device is bent.The cage is slightly bent.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¿ lite device was used during a sacrospinous ligament fixation procedure performed on (b)(6) 2017.According to the complainant, during procedure, when the physician tried to put the needle into the capio cage outside the patient, the lead suture near the dilator broke.The procedure was completed with another uphold¿ lite device.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: 7141024
• MDR Text Key: 95909259
• Report Number: 3005099803-2017-03674
• 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: 11/23/2017

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: 02/17/2020
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Device Lot Number: 0000056829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2017
• Initial Date FDA Received: 12/21/2017
• Supplement Dates Manufacturer Received: 12/29/2017
• Supplement Dates FDA Received: 01/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2017
• 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 Age: 86 YR
• Patient Weight: 52