MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-25 for X-PORT ISP WITH GROSHONG CATHETER - JAPAN ONLY 7707540J manufactured by Bard Access Systems.
[187597867]
Photos were provided for review. The device has not been returned to the manufacturer for evaluation. As the lot number for the device was not provided, a review of the device history records has not been performed. The investigation of the reported event is currently underway.
Patient Sequence No: 1, Text Type: N, H10
[187597868]
It was reported that approximately one year two months post port device implant, a thrombus-like fibrin sheath was allegedly adhered around the port catheter; however, blood flowed inside the catheter. It was further reported that imaging demonstrated thrombus in the left subclavian vein, which was dissolved. Reportedly, the port device was removed. The patient status is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2020-01057 |
| MDR Report Key | 9881024 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-01-20 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-03-25 |
| 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 | JUDITH LUDWIG |
| Manufacturer Street | 1415 W. 3RD STREET |
| Manufacturer City | TEMPE AZ 85281 |
| Manufacturer Country | US |
| Manufacturer Postal | 85281 |
| Manufacturer Phone | 4803032689 |
| Manufacturer G1 | BARD REYNOSA S.A. DE C.V. |
| Manufacturer Street | BLVD MONTEBELLO #1 PARQUE INDUSTRIAL COLONIAL |
| Manufacturer City | REYNOSA TAMAULIPAS 88780 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88780 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | X-PORT ISP WITH GROSHONG CATHETER - JAPAN ONLY |
| Generic Name | IMPLANTABLE PORT |
| Product Code | LJT |
| Date Received | 2020-03-25 |
| Returned To Mfg | 2020-03-02 |
| Catalog Number | 7707540J |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD ACCESS SYSTEMS |
| Manufacturer Address | 605 N. 5600 W. SALT LAKE CITY UT 84116 US 84116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2020-03-25 |