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 Known Impact Or Consequence To Patient (2692)

Event Date 08/04/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Mfg.Site name - (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 medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an uphold¿ lite was used during an unknown procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the capio carrier (forceps of the capio needle) broke during the positioning of one of the two mesh arms.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).

Event Description

It was reported to boston scientific corporation that an uphold¿ lite was used during an unknown procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the capio carrier (forceps of the capio needle) broke during the positioning of one of the two mesh arms.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.Additional information received on september 13, 2017.It was the needle that broke off during the positioning of one of the two mesh arms.

• 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 Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 6837242
• MDR Text Key: 84298782
• Report Number: 3005099803-2017-02615
• Device Sequence Number: 1
• Product Code: OTP
• UDI-Device Identifier: 08714729839200
• UDI-Public: (01)08714729839200(17)20200229(10)0000057716
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 08/09/2017

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: 02/29/2020
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Device Lot Number: 0000057716
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/09/2017
• Initial Date FDA Received: 09/01/2017
• Supplement Dates Manufacturer Received: 09/13/2017
• Supplement Dates FDA Received: 10/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2017
• 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 Outcome(s): Other