MAUDE Adverse Event Report: RESHAPE LIFESCIENCES LAP-BAND SYSTEM; ADJUSTABLE GASTRIC BAND

Model Number C-2304

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 11/11/2021

Event Type  malfunction  

Event Description

The patient was implanted with a lap-band on (b)(6) 2010.The patient had an initial port replacement on (b)(6) 2011.During a ct scan of abdomen and pelvis, a fracture in the port tubing was observed.It was noted that the sleeve on the port came off.The surgeon reported that this may have allowed stress on the port tubing, which broke just after the metal post on the older ez port design.The surgeon stated that the older port sleeve was going too loose to stay on the surrounding coupling, and, therefore, the surgeon was afraid it would happen again and replaced the port on (b)(6) 2021.

• Brand Name: LAP-BAND SYSTEM
• Type of Device: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): RESHAPE LIFESCIENCES; 1001 calle amanecer; san clemente CA 92673
• Manufacturer Contact: michelle ravert ; 1001 calle amanecer; san clemente, CA 92673 ; 8449377374
• MDR Report Key: 12964931
• MDR Text Key: 285941341
• Report Number: 3013508647-2021-00043
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/03/2021

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 Model Number: C-2304
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2021
• Initial Date FDA Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 78 KG