MAUDE Adverse Event Report: XERIDIEM MEDICAL DEVICES ENDOVIVE STANDARD BALLOON REPLACEMENT KIT, RIGHT ANGLE BOLSTER, 20FR; GASTROSTOMY TUBE

Model Number	70-0023-020
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	Feeding Problem (1850)
Date of Event	07/08/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Xeridiem (legal manufacturer) part number is 70-0023-020; (b)(4) (exclusive distributor) part number is m00582150; the(b)(4) part number is the one appearing on the label.The device was not able to be returned for evaluation.Instructions for use warnings include one that indicate the device is for single use only.Since the device was not returned for evaluation, a definite root cause for this device's failure could not be determined.The process for manufacturing this device was reviewed, including records for this device's lot number, and no nonconformities were found.
Event or Problem Description
The device was a replacement and they inflated the balloon during the procedure.They noticed the next day that the patient was lethargic or unresponsive.They had some concerns about the tube being dislodged.The physician came in, deflated the tube, reinserted it, reinflated it, and they moved the patient to the icu.They stopped the tube feeding and had a cat scan done later that day.It was after that point that they noticed some air or fluid, so they removed it and put air back in to reinflate the balloon and put it on the table to watch it and the balloon deflated.The balloon deflated and got dislodge.The patient was transferred to rehab within the hospital.Hospital told patient's husband that the product was defective, leaked and caused the patient serious injury.Patient is on a ventilator, unresponsive and is not improving.

• Brand Name: ENDOVIVE STANDARD BALLOON REPLACEMENT KIT, RIGHT ANGLE BOLSTER, 20FR
• Common Device Name: GASTROSTOMY TUBE
• Manufacturer (Section D): XERIDIEM MEDICAL DEVICES; 4700 south overland drive; tucson AZ 85714 3430
• MDR Report Key: 5961638
• Report Number: 2025851-2016-00015
• Device Sequence Number: 98662
• Product Code: KNT
• UDI-Device Identifier: 00813939020045
• UDI-Public: (01)00813939020045(17)170930(10)0929301
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K083684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/09/2016

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: 70-0023-020
• Device Catalogue Number: M00582150
• Device Lot Number: 929301
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2016
• Initial Report FDA Received Date: 09/19/2016
• 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: 55 YR