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 2020-02-25 for DXTERITY TRA UNK-CV-DAN-DXT manufactured by Medtronic, Inc.
[183680602]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[183680603]
A post market clinical follow-up (pmcf) survey was conducted on behalf of medtronic to seek out potential new risks and assess performance of the dxterity diagnostic catheter. Survey results from an interventional cardiologist in practice 15 years. In the past 12 months the physician performed 200 procedures using the dxterity diagnostic catheter. 100 procedures using the 5 fr x 100cm, 50 procedures using the intermediate sizes, and 50 procedures using the 6f x 125cm. The following complications adverse events/effects were encountered when using the dxterity diagnostic catheter over the last 12 months: one dissection event occurred which was related to the procedure but not directly to the medtronic dxterity diagnostic catheter. Two myocardial infarction events occurred which were related to the procedure but not directly to the medtronic dxterity diagnostic catheter. 5 vasospasm events occurred which were related to the procedure but not directly to the medtronic dxterity diagnostic catheter. (no vascular occlusion was reported) it was reported that deformation occurred during use in one case. The event was related to the procedure but not directly to a medtronic dxterity diagnostic catheter.
Patient Sequence No: 1, Text Type: D, B5
[188508031]
The deformation during use event had impact on the procedure, but no clinical/patient impact. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220452-2020-00026 |
| MDR Report Key | 9749337 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-25 |
| Date of Report | 2020-03-25 |
| Date Mfgr Received | 2020-03-05 |
| Date Added to Maude | 2020-02-25 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | MEDTRONIC, INC |
| Manufacturer Street | 37A CHERRY HILL DR |
| Manufacturer City | DANVERS MA 01923 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01923 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DXTERITY TRA |
| Generic Name | CATHETER, INTRAVASCULAR, DIAGNOSTIC |
| Product Code | DQO |
| Date Received | 2020-02-25 |
| Catalog Number | UNK-CV-DAN-DXT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC, INC |
| Manufacturer Address | 37A CHERRY HILL DR DANVERS MA 01923 US 01923 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-25 |