MAUDE Adverse Event Report: XERIDIEM MEDICAL DEVICES ENDOVIVE GASTROSTOMY TUBE, STRAIGHT, WITH ENFIT CONNECTOR

Model Number	70-0051-220
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Edema (1820); Skin Inflammation (2443); Fluid Discharge (2686)
Date of Event	01/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No patient information is available.Model number is xeridiem part number for the device.Catalog number is part number for boston scientific, xeridiem's exclusive distributor for the device.(b)(6).Device was not available to be returned to xeridiem for evaluation.Since the device was not available for evaluation, a definite cause for the cutaneous reaction cannot be determined.However, biocompatibility of the device was verified before release for initial commercial distribution.
Event or Problem Description
The catheter has caused a clear cutaneous reaction, with edema and inflammation of the skin and leakage of liquid.After two months it was necessary to replace the endovive catheter.During removal, nurse found a lot of resistance from the anchoring balloon that was completely filled with encrustations material of unclear origin.The balloon was partially folded in on itself and then anchored inside the fistulous tract.Incident consequence: medical intervention - necessity of early change of the catheter, serious cutaneous reaction, pain in removal phase.

• Brand Name: ENDOVIVE GASTROSTOMY TUBE, STRAIGHT, WITH ENFIT CONNECTOR
• Common Device Name: GASTROSTOMY TUBE
• Manufacturer (Section D): XERIDIEM MEDICAL DEVICES; 4700 s. overland drive; tucson AZ 85714 3430
• MDR Report Key: 8348288
• Report Number: 2025851-2019-00002
• Device Sequence Number: 13933964
• Product Code: PIF
• UDI-Device Identifier: 00813939023626
• UDI-Public: (01)00813939023626(17)210402(10)0977403
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: K142075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/05/2019

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: 04/02/2021
• Device Model Number: 70-0051-220
• Device Catalogue Number: M0509920
• Device Lot Number: 977403
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 02/18/2019
• 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