MAUDE Adverse Event Report: RESHAPE LIFESCIENCES RESHAPE REMOVAL CATHETER

Model Number	01-0012-XXX
Medical Device Problem Codes	Material Puncture/Hole (1504); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/17/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The balloon was inserted on (b)(6) 2018.On (b)(6) 2018 during a routine removal, the needle from the removal catheter detached while attempting to deflate the distal balloon.The needle was recovered by the physician during the procedure.There was no injury to the patient.
Event or Problem Description
The balloon was inserted on (b)(6) 2018.On (b)(6) 2018 during a routine removal, the needle from the removal catheter detached while attempting to deflate the distal balloon.The needle was recovered by the physician during the procedure.There was no injury to the patient.

• Brand Name: RESHAPE REMOVAL CATHETER
• Common Device Name: REMOVAL CATHETER
• Manufacturer (Section D): RESHAPE LIFESCIENCES; 100 calle iglesia; san clemente CA 92672 7502
• MDR Report Key: 7876614
• Report Number: 3007934906-2018-00032
• Device Sequence Number: 1758062
• Product Code: OCX
• UDI-Device Identifier: B001RSM2101
• UDI-Public: B001RSM2101
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P140012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/22/2021
• Device Model Number: 01-0012-XXX
• Device Catalogue Number: RSM210
• Device Lot Number: 180523-005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2018
• Initial Date Received by Manufacturer: 08/17/2018
• Supplement Date Received by Manufacturer: 08/17/2018
• Initial Report FDA Received Date: 09/14/2018
• Supplement Report FDA Received Date: 10/03/2018
• 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: 51 YR