MAUDE Adverse Event Report: XERIDIEM MEDICAL DEVICES ENDOVIVE STANDARD BALLOON REPLACEMENT KIT, RIGHT ANGLE; GASTROSTOMY TUBE

Model Number	70-0023-024
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Discomfort (2330)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4) model number is xeridiem part number; catalog number is part number of exclusive distributor boston scientific that appears on the label.H3, h6) the involved device was returned to xeridiem.Visual inspection noted discoloration (indicating usage of device) but no defect evident from inspection.Functional testing of balloon inflation found it did not sustain inflation.Further testing of inflation with blue dye in water found a pinhole in the balloon as the problem.The root cause of the pinhole could not be determined.Codes in h6 are selected based on the comination of this evaluation and the event description.
Event or Problem Description
After placement of gastrostomy tube, patient came back multiple times with issues including sufficient discomfort to indicate patient code of minor injury/illness/impairment.Physician believed the balloon was not properly working.Physician removed the gastrostomy tube and replaced with a new one which resolved the problem with no further issues.

• Brand Name: ENDOVIVE STANDARD BALLOON REPLACEMENT KIT, RIGHT ANGLE
• Common Device Name: GASTROSTOMY TUBE
• Manufacturer (Section D): XERIDIEM MEDICAL DEVICES; 4700 s. overland drive; tucson AZ 85714 3430
• Manufacturer (Section G): XERIDIEM MEDICAL DEVICES; 4700 s. overland drive; tucson AZ 85714 3430
• Manufacturer Contact: steve murray ; 4700 s. overland drive; tucson 85714-3430 ; 5208827794
• MDR Report Key: 19231926
• Report Number: 2025851-2024-00002
• Device Sequence Number: 5920045
• Product Code: KNT
• UDI-Device Identifier: 00813939020069
• UDI-Public: (01)00813939020069(17)240601(10)1090814
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K083684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/02/2024

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: Health Professional
• Device Expiration Date: 06/01/2024
• Device Model Number: 70-0023-024
• Device Catalogue Number: M00582160
• Device Lot Number: 1090814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2024
• Initial Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown