MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-11 for HAWKONE 6FR H1-M manufactured by Medtronic Ireland.
[184390141]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[184390142]
Physician intended to use a hawkone with a non-medtronic 6fr sheath and 0. 014 non-medtronic wire during treatment of a calcified/fibrous lesion in the patient? S mid right superficial femoral artery (sfa) of diameter 6mm. Moderate vessel calcification reported. Lesion exhibited 80% stenosis. Ifu was followed. Vessel pre-dilation not performed. It is reported that when packing the resistance felt resistance in the thumbswitch and observed on x-ray that the cutter appeared to have partially detached from the shaft. There was a slight separation noted in the cutter. The tip did not separate at the hinge pin. The cutter blade was located inside the housing. The device was safely removed from the patient. A new hawkone device was opened to complete the procedure. No injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612164-2020-01105 |
| MDR Report Key | 9816483 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2020-01-17 |
| Date Added to Maude | 2020-03-11 |
| 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 | TONI O'DOHERTY |
| Manufacturer Street | PARKMORE BUSINESS PARK WEST |
| Manufacturer City | GALWAY |
| Manufacturer Country | IE |
| Manufacturer Phone | 091708734 |
| Manufacturer G1 | MEDTRONIC IRELAND |
| Manufacturer Street | PARKMORE BUSINESS PARK WEST |
| Manufacturer City | GALWAY |
| Manufacturer Country | IE |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HAWKONE 6FR |
| Generic Name | CATHETER, PERIPHERAL, ATHERECTOMY |
| Product Code | MCW |
| Date Received | 2020-03-11 |
| Model Number | H1-M |
| Catalog Number | H1-M |
| Lot Number | 0010097314 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC IRELAND |
| Manufacturer Address | PARKMORE BUSINESS PARK WEST GALWAY IE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-11 |