MAUDE Adverse Event Report: RESHAPE LIFESCIENCES RESHAPE INTEGRATED DUAL BALLOON SYSTEM; INTRAGASTRIC BALLOON

Model Number 01-0011-001

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/18/2018

Event Type  malfunction  

Event Description

Gastric balloon ruptured and was removed on (b)(6) 2018.Unable to obtain additional information regarding the patient status or details related to the ruptured balloon.

Manufacturer Narrative

The product returned for evaluation, updated mdr to reflect this change.

Event Description

Gastric balloon ruptured and was removed on (b)(6) 2018.Unable to obtain additional information regarding the patient status or details related to the ruptured balloon.

• Brand Name: RESHAPE INTEGRATED DUAL BALLOON SYSTEM
• Type of Device: INTRAGASTRIC BALLOON
• Manufacturer (Section D): RESHAPE LIFESCIENCES; 100 calle iglesia; san clemente CA 92672 7502
• Manufacturer (Section G): RESHAPE LIFESCIENCES; 100 calle iglesia; san clemente CA 92672 7502
• Manufacturer Contact: kristin wielenga ; 100 calle iglesia; san clemente, CA 92672-7502 ; 9492188639
• MDR Report Key: 7683692
• MDR Text Key: 113875033
• Report Number: 3007934906-2018-00023
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: B001RSM1011
• UDI-Public: B001RSM1011
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 01-0011-001
• Device Catalogue Number: RSM101
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2018
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Required Intervention