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

Model Number 01-0008

Device Problems Activation, Positioning or Separation Problem (2906); Positioning Problem (3009)

Patient Problem Obstruction/Occlusion (2422)

Event Date 04/24/2018

Event Type  Injury  

Event Description

The patient had the balloons inserted on (b)(6) 2018.During the insertion, the physician had difficulty passing the balloon catheter over the wire due to difficult patient anatomy.The patient had excessive epiglottic and hypopharyneal tissue which was not allowing the passing of the catheter.This caused trauma and swelling to the hypopharynx.The physician aborted the procedure.Reshape medical has reached out to the customer regarding the patient status post operatively.

Manufacturer Narrative

The actual device was not returned; however, a review of the manufacturing records was performed and there were no non-conformances found.

Event Description

The patient had the balloons inserted on (b)(6) 2018.During the insertion, the physician had difficulty passing the balloon catheter over the wire due to difficult patient anatomy.The patient had excessive epiglottic and hypopharyngeal tissue which was not allowing the passing of the catheter.This caused trauma and swelling to the hypopharynx.The physician aborted the procedure.Reshape medical has not been able to obtain the patient status.

• Brand Name: RESHAPE INTEGRATED DUAL BALLOON SYSTEM
• Type of Device: INTRAGASTRIC BALLOON
• Manufacturer (Section D): RESHAPE MEDICAL; 100 calle iglesia; san clemente CA 92672 7502
• Manufacturer (Section G): RESHAPE MEDICAL; 100 calle iglesia; san clemente CA 92672 7502
• Manufacturer Contact: kristin wielenga ; 100 calle iglesia; san clemente, CA 92672-7502 ; 9492188639
• MDR Report Key: 7541073
• MDR Text Key: 109147464
• Report Number: 3007934906-2018-00019
• 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,Followup
• Report Date: 07/18/2018

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?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/23/2019
• Device Model Number: 01-0008
• Device Catalogue Number: RSM300
• Device Lot Number: 126635
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/27/2018
• Initial Date FDA Received: 05/24/2018
• Supplement Dates Manufacturer Received: 04/27/2018
• Supplement Dates FDA Received: 07/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 35 YR