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 2020-02-24 for DXTERITY TRA UNK-CV-DAN-DXT manufactured by Medtronic, Inc.
[188486460]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188486461]
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 were obtained from an cardiovascular surgeon in practice 20 years. In the past 12 months the physician performed 180 procedures using the dxterity diagnostic catheter. 30 procedures using the 5 fr x 100cm, 120 procedures using the intermediate sizes, and 30 procedures using the 6f x 125cm. The following complications adverse events/effects were reported when using the dxterity diagnostic catheter product over the last 12 months. 2 dissection events occurred which were related to a pre-existing condition or comorbidity. 4 thrombus formation events occurred which were related to a pre-existing condition or comorbidity. 3 embolization events occurred which was related to a pre-existing condition or comorbidity. 6 cardiac arrhythmia events occurred which were related to a pre-existing condition or comorbidity. 2 myocardial infarction events occurred which were related to a pre-existing condition or comorbidity. 4 stroke and transient ischemic attack events occurred which were related to a pre-existing condition or comorbidity. 5 infection events occurred which were related to a pre-existing condition or comorbidity. 10 allergic reaction events occurred which were related to a pre-existing condition or comorbidity. 8 vasospasm events occurred which were related to a pre-existing condition or comorbidity. 4 devices were damaged in the package before use. The events were directly related to the dxterity diagnostic catheter. The events were reported to be due to transport or storage issues. 5 devices were damaged when removed from the package. The events were directly related to the dxterity diagnostic catheter. The events were reported to be due to transport or storage issues. 3 devices had a defective tip. 2 events were related to the procedure but not directly to the dxterity diagnostic catheter. One event was directly related to the dxterity diagnostic catheter. The events were alleged to be due to a defect during manufacturing. For 3 devices, the tip broke off/was damaged. 2 events were related to the procedure but not directly to the dxterity diagnostic catheter. One event was directly related to the dxterity diagnostic catheter. The events were alleged to be due to a defect during manufacturing.
Patient Sequence No: 1, Text Type: D, B5
[188509467]
The damage when removed from package events had no clinical/patient impact. The defective tip events had no clinical/patient impact. The tip broke off/was damaged events had no clinical/patient impact. None of the events had an impact on the procedure. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220452-2020-00024 |
| MDR Report Key | 9744282 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-24 |
| Date of Report | 2020-03-25 |
| Date Mfgr Received | 2020-03-05 |
| Date Added to Maude | 2020-02-24 |
| 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 | 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 | 2020-02-24 |
| 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 | 2020-02-24 |