MAUDE Adverse Event Report: RESHAPE MEDICAL, INC. RESHAPE INTEGRATED DUAL BALLOON SYSTEM; INTRAGASTRIC BALLOON

Model Number 01-0011-001

Device Problem Premature Activation (1484)

Patient Problem Hypoxia (1918)

Event Date 06/09/2017

Event Type  Injury  

Event Description

The subject underwent reshape balloon insertion procedure on (b)(6) 2017.Per md, he experienced difficulty and resistance while trying to advance the balloon through the pharnyx and esophagus.Md decided to remove the delivery catheter/balloon assembly to apply additional lubrication and then reinsert.As he retracted the deliver catheter, the balloon detached from the catheter, leaving the balloons in the posterior pharynx and across the upper esophageal sphincter (ues).Patient's o2 saturation levels dropped until md was able to retrieve the balloon using magill forceps.Md speculated that a ues spasm may have impeded retraction of the balloon.Due to the temporary airway compromise, patient was admitted to the hospital for observation on (b)(6) 2017 and was discharged in stable condition the next morning ((b)(6) 2017) with no further sequelae.

• Brand Name: RESHAPE INTEGRATED DUAL BALLOON SYSTEM
• Type of Device: INTRAGASTRIC BALLOON
• Manufacturer (Section D): RESHAPE MEDICAL, INC.; 100 calle iglesia; san clemente CA 92672 7502
• Manufacturer (Section G): RESHAPE MEDICAL, INC.; 100 calle iglesia; san clemente CA 92672 7502
• Manufacturer Contact: mary lou mooney ; 100 calle iglesia; san clemente, CA 92672-7502 ; 9494296680
• MDR Report Key: 6704712
• MDR Text Key: 79728208
• Report Number: 3007934906-2017-00019
• 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
• Report Date: 07/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/31/2017
• Device Model Number: 01-0011-001
• Device Catalogue Number: RSM101
• Device Lot Number: 161031-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/12/2017
• Initial Date Manufacturer Received: 06/12/2017
• Initial Date FDA Received: 07/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2016
• 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): Hospitalization
• Patient Age: 52 YR