MAUDE Adverse Event Report: OBTECH MEDICAL SARL_ VELOCITY INJECTION PORT AND APPLIER; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number PT2XV

Device Problems Disconnection (1171); Device Operates Differently Than Expected (2913)

Patient Problem Surgical procedure (2357)

Event Date 04/23/2015

Event Type  malfunction  

Event Description

The adjustment port became disconnected from the tubing of the gastric band - patient lost confidence in the device and asked that it be removed rather than reconnected.The port and band were removed.

Manufacturer Narrative

(b)(4).No device received for analysis at time of submission of 3500a.When additional information is received and/or the device analysis has been completed, a supplemental medwatch will be sent.The following information was requested, but unavailable: what is the patient¿s current status? can you please confirm if the lot number is correct zwwbbb? has the patient had any adjustments or has the port been accessed? how was the port disconnect detected? please document your answer ? was the locking connector attached to the port? was the strain relief found? is this the first incident of port disconnection? will the device be returned for investigation?.

• Brand Name: VELOCITY INJECTION PORT AND APPLIER
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): OBTECH MEDICAL SARL_; chemin-blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer (Section G): OBTECH MEDICAL SARL; chemin-blanc 38; le locle CH-2 400; SZ CH-2400
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4750062
• MDR Text Key: 5768577
• Report Number: 3005992282-2015-00020
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/27/2015

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: 09/01/2016
• Device Catalogue Number: PT2XV
• Device Lot Number: ZWWBBB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/27/2015
• Initial Date FDA Received: 05/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1