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

Model Number 70-0051-220

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problems Edema (1820); Skin Inflammation (2443); Fluid Discharge (2686)

Event Date 01/10/2019

Event Type  Injury  

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 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
• Type of Device: 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, AZ 85714-3430 ; 5208827794
• MDR Report Key: 8348288
• MDR Text Key: 136487296
• Report Number: 2025851-2019-00002
• Device Sequence Number: 1
• Product Code: PIF
• UDI-Device Identifier: 00813939023626
• UDI-Public: (01)00813939023626(17)210402(10)0977403
• Combination Product (y/n): N
• Reporter Country Code: CS
• PMA/PMN Number: K142075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 02/05/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention