MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-27 for LEADER-CATH 115.090 manufactured by Vygon.
[181402359]
The failed sample will be returned to vygon for device evaluation as part of the complaint investigation. The results of this investigation are still pending, and will be communicated to fda within 30 days of its conclusion. The batch review of this batch shows that the product is compliant to its specification. The tensile strength is conform to iso norm.
Patient Sequence No: 1, Text Type: N, H10
[181402360]
Patients artery scanned, device still in situ in radial artery, advice sort from vascular consultant. Patient review by vascular consultant (b)(6) 2020 due to the patients poor clinical condition no further action is required and the retention of the arterial line is unlikely to have a direct impact on the patient. The patient is frail and elderly post hemiarthroplasty surgery and has cognitive impairment with lack of ability to retain short term memory. The orthopaedic team have been asked to ensure that the retained of the part is clearly outlined within communication to the patients gp and the reason to leave the remaining part in situ. The patients nok have been spoken to and are aware of the impact to the patient and the advice offered from the vascular team.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2245270-2020-00011 |
| MDR Report Key | 9762533 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-27 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-02-10 |
| Date Mfgr Received | 2020-02-19 |
| Date Added to Maude | 2020-02-27 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | FREDA LACROIX |
| Manufacturer Street | 2750 MORRIS ROAD |
| Manufacturer City | LANSDALE, PA |
| Manufacturer Country | US |
| Manufacturer Phone | 4735414237 |
| Manufacturer G1 | VYGON |
| Manufacturer Street | 5 RUE ADELINE |
| Manufacturer City | ECOUEN 95440 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 95440 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEADER-CATH |
| Generic Name | INTRAVASCULAR CATHETER |
| Product Code | DQO |
| Date Received | 2020-02-27 |
| Model Number | 115.090 |
| Catalog Number | 115.090 |
| Lot Number | 8094298 OR 8095049 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYGON |
| Manufacturer Address | 5 RUE ADELINE ECOUEN 95440 FR 95440 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-27 |