MAUDE Adverse Event Report: OBTECH MEDICAL SARL_ GEN2 ADJUSTABLE GASTRIC BAND - 11 CM, UNLOCKA; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number BD3XV

Device Problems Air Leak (1008); Hole In Material (1293)

Patient Problem No Patient Involvement (2645)

Event Date 09/15/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information: port applier, port & red cap in unopened packaging and band with full catheter attached was returned.The lot number etched on the band is zrcbbd.The complaint alleges balloon leakage.Leak test performed and the product failed the test.A leak was evident on the band.There is a minute hole visible on the band.This is a clean cut hole, not a tear, which may suggest needle / sharp object perforation.A device history records (dhr) review was carried out and no discrepancies in relation to this event were noted on the file.A review of the manufacturing process was performed and it is noted that all products are 100% leak tested prior to release; therefore it is unlikely that a manufacturing issue contributed to the reported event.

Event Description

It was reported that prior to use of the device in a gastric banding procedure, when the scrub nurse pre-tested the device (put band in bowl of water), some bubbles came out and there was one little hole in the band.A new device was opened and used instead.No patient involvement.

Manufacturer Narrative

(b)(4).At the time of this submission, the device has not been returned for analysis.If the device or further details are received at a later date a supplemental medwatch will be sent.

• Brand Name: GEN2 ADJUSTABLE GASTRIC BAND - 11 CM, UNLOCKA
• 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: 4140861
• MDR Text Key: 12606918
• Report Number: 3005992282-2014-00055
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 09/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: BD3XV
• Device Lot Number: ZRFBBK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1