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

Catalog Number BD3XV

Device Problems Device Operates Differently Than Expected (2913); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We did not receive a batch or lot number for the product involved in this complaint.Therefore, we were unable to check manufacturing records for any related non-conformance.

Event Description

It was reported that during a gastric band implant procedure the doctor had to expand it again.The reason for the expansion was that the shutter mechanism worked, but the tape was torn.Another like device was used to complete the procedure.There were no adverse consequences reported for the patient.

Manufacturer Narrative

(b)(4).Date sent: 5/1/2017.Photo analysis: four pictures were provided; first two pictures, are from an x ray of the bd3xv band, the pictures are blurry, the images cannot be appreciated.Third and fourth picture shows the band with no buckle and lock indicator / diamond present.Based on the photo alone, the event described is confirmed, unfortunately, there is not enough evidence in the photo to determine root cause.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.No lot or batch were provided, batch history review could not be performed.

Manufacturer Narrative

(b)(4).Date sent: 7/27/2017.Batch # zppbbg.The bd3xv device was received with the lock indicator detached and no suture present.Components were returned as follows: a gastric band, velocity port with 23 cm of tubing, and in addition 30.5 cm loose as if the tube was cut.No functional test was performed due to the event described was confirmed with the lock indicator detached.Manufacturing performed visual inspection on 100% of products prior to product release; therefore, a manufacturing issue is unlikely to have contributed to the event.The dhr was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

• 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-24 00; SZ CH-2400
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 6463745
• MDR Text Key: 72340697
• Report Number: 3005992282-2017-00005
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: BD3XV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1