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

Model Number M0068318170

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2015

Event Type  malfunction  

Event Description

Note: this report pertains to the second of two devices used during the same procedure.Manufacturer report# 3005099803-2015-00429 captures the first device.It was reported to boston scientific corporation that an uphold lite with capio slim was used during a prolapse procedure performed on (b)(6) 2015.According to the complainant, during the procedure, the needle broke off from the suture but it was caught and retrieved by the capio slim device.They opened a second uphold lite with capio slim but found hair inside the sterile packaging.They did not use the second device.The procedure was completed with a third uphold lite with capio slim.The patient's condition at the conclusion of the procedure was reported to be fine.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

Manufacturer Narrative

Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.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.

Manufacturer Narrative

Visual evaluation of the returned uphold lite with capio slim revealed that the package was returned open.There was no foreign matter inside the package and the event cannot be confirmed.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.All available information fail to indicate a root cause or probable root cause.Therefore, the root cause of this complaint is undeterminable.

Event Description

Note: this report pertains to the second of two devices used during the same procedure.Manufacturer report# 3005099803-2015-00429 captures the first device.It was reported to boston scientific corporation that an uphold lite with capio slim was used during a prolapse procedure performed on (b)(6) 2015.According to the complainant, during the procedure, the needle broke off from the suture but it was caught and retrieved by the capio slim device.They opened a second uphold lite with capio slim but found hair inside the sterile packaging.They did not use the second device.The procedure was completed with a third uphold lite with capio slim.The patient's condition at the conclusion of the procedure was reported to be fine.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

• 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: 4569963
• MDR Text Key: 5476960
• Report Number: 3005099803-2015-00430
• 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: 02/06/2015

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: 09/30/2017
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Device Lot Number: ML00002605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2015
• Initial Date FDA Received: 03/04/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2014
• 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: 61 YR
• Patient Weight: 61