MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,user facility report with the FDA on 2019-02-18 for ENDOVIVE GASTROSTOMY TUBE, STRAIGHT, WITH ENFIT CONNECTOR 70-0051-220 M0509920 manufactured by Xeridiem Medical Devices.
[136487296]
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.
Patient Sequence No: 1, Text Type: N, H10
[136487297]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025851-2019-00002 |
| MDR Report Key | 8348288 |
| Report Source | DISTRIBUTOR,USER FACILITY |
| Date Received | 2019-02-18 |
| Date of Report | 2019-02-05 |
| Date of Event | 2019-01-10 |
| Date Mfgr Received | 2019-02-05 |
| Date Added to Maude | 2019-02-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. STEVE MURRAY |
| Manufacturer Street | 4700 S. OVERLAND DRIVE |
| Manufacturer City | TUCSON AZ 857143430 |
| Manufacturer Country | US |
| Manufacturer Postal | 857143430 |
| Manufacturer Phone | 5208827794 |
| Manufacturer G1 | XERIDIEM MEDICAL DEVICES |
| Manufacturer Street | 4700 S. OVERLAND DRIVE |
| Manufacturer City | TUCSON AZ 857143430 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 857143430 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOVIVE GASTROSTOMY TUBE, STRAIGHT, WITH ENFIT CONNECTOR |
| Generic Name | GASTROSTOMY TUBE |
| Product Code | PIF |
| Date Received | 2019-02-18 |
| Model Number | 70-0051-220 |
| Catalog Number | M0509920 |
| Lot Number | 977403 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | XERIDIEM MEDICAL DEVICES |
| Manufacturer Address | 4700 S. OVERLAND DRIVE TUCSON AZ 857143430 US 857143430 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-02-18 |