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 2020-03-23 for BTK TURBOHAWK THS-SX-C manufactured by Medtronic Ireland.
[184492748]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[184492749]
Physician used a turbohawk device during treatment a plaque lesion in the patient? S mid tibial/popliteal trunk. Slight vessel tortuosity and calcification are reported. It is reported during the procedure resistance was encountered during advancement. It is reported the cutter on the device was damaged. No pieces or chips were missing from the cutter. The cutter was located inside the housing upon device removal. The device was safely removed from the patient. No vessel damage was noted. It is reported that a small piece of wire was removed from the device with a pair of tweezers. A new device was opened. No complications were reported from the defective device. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612164-2020-01270 |
| MDR Report Key | 9864347 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-03-09 |
| Date Mfgr Received | 2020-03-19 |
| Device Manufacturer Date | 2019-12-06 |
| Date Added to Maude | 2020-03-23 |
| 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 | BTK TURBOHAWK |
| Generic Name | CATHETER, PERIPHERAL, ATHERECTOMY |
| Product Code | MCW |
| Date Received | 2020-03-23 |
| Model Number | THS-SX-C |
| Catalog Number | THS-SX-C |
| Lot Number | 0010047976 |
| 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 | 2020-03-23 |