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

Model Number	01-0008
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Positioning Problem (3009)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	04/24/2018
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: INTRAGASTRIC BALLOON
• Manufacturer (Section D): RESHAPE MEDICAL; 100 calle iglesia; san clemente CA 92672 7502
• MDR Report Key: 7541073
• Report Number: 3007934906-2018-00019
• Device Sequence Number: 16598979
• Product Code: LTI
• UDI-Device Identifier: B001RSM1011
• UDI-Public: B001RSM1011
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P140012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/27/2018
• Supplement Date Received by Manufacturer: 04/27/2018
• Initial Report FDA Received Date: 05/24/2018
• Supplement Report FDA Received Date: 07/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR