MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. VELOCITY PORT WITH GAST BAND; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number BD2XV

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/14/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent: 9/8/2020.Batch # zjlbkk.The initial details of this report was originally submitted with tracking #: pi1-va28h1 sent on: 9/12/2015.The report was inadvertently marked as follow-up #1.It is being re-submitted as the initial report with all details contained.Upon visual examination, the swedish adjustable gastric band (sagb) was torn at both sides of the silicone adjacent to the point of the catheter connection to the device balloon.No buckle was returned with the device.Obtech medical has performed a previous internal investigation in an effort to establish possible root cause of this type of buckle failure.Engineering testing indicated that this type of failure mode could only be replicated, when the buckle area of the band was damaged prior to bench top tensile testing.Concluding statements indicated that damage to the window area of the band, either by surgical graspers or surgical scissors can lead to failure in this area.The strength of the band may also be compromised if this damage occurs.The lock end flaps were attached via suture.The suturing of the lock end flaps was not performed in accordance to ifu guidelines: ¿caution: if the band is unlocked for any reason, relock the band, and place a suture through both reinforcing band flaps.Place the suture through the diamond lock indicator on the lock-end flap¿.A device history record (dhr) review was performed, and no discrepancies were recorded during the manufacturing of this band in relation to the event described.All devices are 100% visually inspected.Therefore it is unlikely that the manufacturing process has contributed at this issue.The following information was requested, but unavailable: can you please clarify the order of the events reported? does the event description reported, refer to 1, 2 or 3 different products used for the same person? a band (bd2xv or bd3xv?) was implanted on october -7- 2009? (product one?) this device was later removed and the ¿bar¿ had to be cut to facilitate band removal.The patient was seen again by the surgeon in june 2013 to remove some fluid from the band as reported weight loss was good.(was a replacement band implanted? was this a bd3xv?) (product two?) in (b)(6) 2014, the patient received a fill however no improvement was seen in her weight loss.The patient later received two other fills.In (b)(6) 2015 a contrast study was performed under x-ray which identified that the band had become unfastened.The surgeon removed this band today ((b)(6) 2015) and replaced with a bd3xv (third product).One device will be returned.What are the lot numbers of the bands implanted? please identify each product per the implantation period of each band with the associated lot number.Please specify the product codes for each band implanted? what size trocar was used to place the band? any difficulties getting the band through the trocar? any difficulties with band placement? the event description reads ¿the buckle on the device had completely sheared away and therefore was no longer working¿ ¿ how was the band tab damage identified?.

Event Description

It was reported that at an unknown time for an unknown procedure, ¿the surgeon has removed a swedish band today of the second generation as the buckle on the device had completely sheared away and therefore was no longer working.The band was originally put in the patient on (b)(6) 2009.To remove the device he has re-operated and cut away at the bar to take out.The surgeon saw the patient in (b)(6) 2013 to take some fluid out of the band, her weight loss was good.Then in (b)(6) last year he put some more fluid back into the band, but there was no improvement, he did this on a further two occasions.He then x-rayed the patient in (b)(6) of this year and then did a contrast study and identified that the band had unfastened.He has removed this today and replaced with bd3xv.

• Brand Name: VELOCITY PORT WITH GAST BAND
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; * 00969 ; 6107428552
• MDR Report Key: 5073351
• MDR Text Key: 216370471
• Report Number: 3005992282-2015-00041
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2010
• Device Catalogue Number: BD2XV
• Device Lot Number: ZJNBBV
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2008
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female