MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN V-LOC 90; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	VLOCM0114
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/20/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, on (b)(6) 2017, intra-operatively in a pacemaker placement, the device kept breaking while suturing, one product was already detached from the strand.The patient was alive with no injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information: the welded loop of the device broke at the end of the procedure.The surgeon was using a continuous suturing technique.Another suture was opened to complete the case.
Additional Manufacturer Narrative
Investigation summary: post market vigilance (pmv) led an evaluation of one device.A tactile and microscopic inspection of the sutures was performed with no abnormalities.The foil was inspected with light assisted microscopy with no abnormalities.Pmv performed functional testing which included a needle attachment test on the sealed sample and the results exceeded the specifications for this product.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all manufacturer's quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.If information is provided in the future, a supplemental report will be issued.

• Brand Name: V-LOC 90
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mc dermott rd; north haven CT 06473
• MDR Report Key: 6803647
• Report Number: 1219930-2017-06498
• Device Sequence Number: 13883817
• Product Code: GAM
• UDI-Device Identifier: 10884521131750
• UDI-Public: 10884521131750
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/17/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: VLOCM0114
• Device Catalogue Number: VLOCM0114
• Device Lot Number: A6B0658VEX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2017
• Initial Date Received by Manufacturer: 07/20/2017
• Supplement Date Received by Manufacturer: 10/04/2017; 12/22/2017
• Initial Report FDA Received Date: 08/18/2017
• Supplement Report FDA Received Date: 11/02/2017; 01/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1