MAUDE Adverse Event Report: OBTECH MEDICAL SARL_ SAGB VELOCITY CURVED BAND; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number BD3XV

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2014

Event Type  malfunction  

Event Description

It was reported that during a laparoscopic band procedure, the surgeon, placed the band inside the patient.As he was positioning it, he noticed that part of the buckle mechanism was torn.He does not believe it was due to placing it down the trocar as no resistance was felt when inserting it.He removed the band and opened another one, which was placed without issue.There was less than five minutes time added to the procedure and no adverse patient outcome.

Manufacturer Narrative

(b)(4).Additional information: one curved adjustable gastric band was returned with the packaging label, port applier, balloon with the extender strap including the black cutting indicator & still attached and a cut along one arm of the buckle.The port, red safety cap, locking connector, and additional extender strap which has a tear / a missing chunk of silicone were also returned.No functional tests were performed as event description alleged a tear along the buckle only.The complaint is confirmed.The tear along the buckle is not a clean cut.A clean cut would insinuate a sharp instrument had caused the tear.No definitive root cause can be attributed here.However as per ifu the use of force whilst inserting the band, using either the push or pull method, may result in this type of failure.A review of the ifu was carried out and it is clearly indicated that care and attention needs to be paid when inserting the band to avoid band damage.A device history record (dhr) 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 it is unlikely that a manufacturing issue contributed to this issue.

Manufacturer Narrative

(b)(4): information is unavailable.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.At the time of this submission, the device has not been returned for analysis.

• Brand Name: SAGB VELOCITY CURVED BAND
• 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: 3981580
• MDR Text Key: 4889475
• Report Number: 3005992282-2014-00046
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2017
• Device Catalogue Number: BD3XV
• Device Lot Number: ZNNBB6
• Other Device ID Number: BATCH # UNK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2012
• 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