MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. CUR.ADJ.BAND WITH PORT+APPLIER; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number BD3XV

Device Problem Obstruction of Flow (2423)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 03/07/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Attempts made to retrieve the device, to date the device has not been returned.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.

Event Description

It was reported that the original bd3xv was implanted on (b)(6) 2008.They were unable to insert or draw fluid from the port.Testing performed showed the port was not disconnected or loose at the site.On (b)(6) 2019 the port was removed due to the port blockage.A new bd3xv was implanted.

Manufacturer Narrative

(b)(4).Date sent: 4/12/2019.Investigation summary the analysis results found that a velocity port was received with an identification (b)(4) and with no apparent damaged.Tissue was noted around the device and 5 punctures in the septum were observed.Also, the knifes were locked.A leak test was performed and no anomalies were noted.The complaint cannot be confirmed as the injection port and port applier were returned fully functional.This report is not intended to deny that you experienced a problem with the device.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.No lot or batch were provided; therefore, the manufacturing records evaluation could not be performed.

• Brand Name: CUR.ADJ.BAND WITH PORT+APPLIER
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8437928
• MDR Text Key: 139579186
• Report Number: 3005075853-2019-17420
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BD3XV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2019
• Initial Date Manufacturer Received: 03/11/2019
• Initial Date FDA Received: 03/20/2019
• Supplement Dates Manufacturer Received: 03/11/2019
• Supplement Dates FDA Received: 04/12/2019
• Patient Sequence Number: 1