MAUDE Adverse Event Report: OBTECH MEDICAL SARL_

Catalog Number RLZB32

Device Problems Filling Problem (1233); Fluid/Blood Leak (1250)

Patient Problem Other (for use when an appropriate patient code cannot be identified) (2200)

Event Date 09/11/2014

Event Type  malfunction  

Event Description

It was reported that after a realize band placement procedure on (b)(6) 2014, the patient had a fill on (b)(6) 2014 of 3cc's and a fill on (b)(6) 2014 of 2cc's.The patient then came into office today and had a fill of 3cc's but patient felt no restriction.The nurse first assistant said they injected the port with methylene blue under fluoro and it showed a leak at the band, close to the esophagus.The nurse first assistant said patient needs surgery for the leaking band.

Manufacturer Narrative

(b)(4).Information asked for but unknown or not provided during initial contact.Information not available, device not returned for analysis.Should the information be provided later, a supplemental medwatch will be sent.

Manufacturer Narrative

(b)(4).Additional information: a leak in the band has been confirmed utilizing contrast; however, the doctor could not tell specifically where the leak was originating as it was not a ct scan.They plan to remove the band and will be providing the band for analysis.Components were returned as follows: the port, engraved with lot number zpgbb9.Biological debris was evident on the port.The band/balloon, engraved with lot number zpgbbz, with approx.42 cm of catheter attached.The band was returned without the buckle.The locking connector and tubing strain relief were returned detached from the device.Leak testing was performed on the band/balloon and no air bubbles were visible.No leak on the band/balloon was evident.Leakage was observed on the end of the catheter where the catheter connects to the hose of the port.No leakage was observed on the balloon or port.Upon visual inspection, two tears were evident on the catheter, however no leak was identified.It is suggested that the damage may have been caused by a sharp instrument.Perforations were evident on the tubing strain relief - this is likely due to needle puncture.It is noted that the measurements of the perforation areas on the catheter end and the tubing strain relief do not align.It is also noted that if the locking connector was correctly secured in the locked position the perforation areas on the catheter end would not have been easily accessible.Root cause is difficult to assign.The port septum was examined under microscopic view, and 11 punctures were evident on the septum.This suggests that several adjustments were performed.A device history record review was performed and no anomalies were found with respect to the manufacturing process.It was also noted that products are 100% inspected prior to distribution therefore a manufacturing issue is unlikely to have contributed to the event.

Manufacturer Narrative

(b)(4).

• 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: 4093560
• MDR Text Key: 4761736
• Report Number: 3005992282-2014-00052
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/11/2014

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: 04/30/2016
• Device Catalogue Number: RLZB32
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/06/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/19/2015
• Initial Date FDA Received: 09/16/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/03/2015; 06/15/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/10/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1