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 2020-03-13 for ATK TURBOHAWK CALCIUM THS-LS-C manufactured by Covidien.
[183284279]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[183284280]
Physician intended to use a turbohawk atherectomy device during treatment of a calcified lesion in the patient? S distal superficial femoral artery (sfa) of diameter 6 mm. Severe vessel calcification and moderate tortuosity are reported. Ifu was followed and the device was prepped without issue. It is reported the catheter jammed with the filter. This occurred when the procedure was almost finished. The physician removed the catheter from the patient safely and without injury. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2029214-2020-00217 |
| MDR Report Key | 9828128 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-26 |
| Date Mfgr Received | 2020-03-23 |
| Device Manufacturer Date | 2016-08-04 |
| Date Added to Maude | 2020-03-13 |
| 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 Phone | 091708734 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 9775 TOLEDO WAY |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ATK TURBOHAWK CALCIUM |
| Generic Name | CATHETER, PERIPHERAL, ATHERECTOMY |
| Product Code | MCW |
| Date Received | 2020-03-13 |
| Returned To Mfg | 2020-03-24 |
| Model Number | THS-LS-C |
| Catalog Number | THS-LS-C |
| Lot Number | A322033 |
| Device Expiration Date | 2019-08-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 9775 TOLEDO WAY IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-13 |