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 2020-03-16 for ADVISOR? HD GRID MAPPING CATHETER, SENSOR ENABLED? D-AVHD-DF16 manufactured by St. Jude Medical.
[183565950]
The results/method and conclusion codes along with investigation results will be provided in the final report.
Patient Sequence No: 1, Text Type: N, H10
[183565951]
Related manufacturing reference: 3005334138-2020-00111. Following an atypical right atrial flutter procedure, an entanglement requiring snare removal occurred. When the sheaths and catheters were being removed from the patient, withdrawal difficulty was noted with the advisor catheter. Fluoroscopy confirmed the catheter was caused in the distal end of the sheath. Manipulation of the catheter was attempted to release the catheter and sheared the introducer that was adjacent to the device in two pieces. The proximal portion of the sheath was removed, but a snaring tool was utilized to remove the distal portion of the sheath, which appeared to be fully removed from the vein. It was indicated by the physician that the advisor had wrapped around the sheath and became entangled. The patient was stable and the procedure was able to be completed. There was no damaged noted to the catheter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005334138-2020-00106 |
| MDR Report Key | 9835190 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-16 |
| Date of Event | 2020-02-24 |
| Date Mfgr Received | 2020-02-24 |
| Device Manufacturer Date | 2019-06-18 |
| Date Added to Maude | 2020-03-16 |
| 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 | STEPHANIE O' SULLIVAN |
| Manufacturer Street | 5050 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 6517565400 |
| Manufacturer G1 | ST. JUDE MEDICAL (AFD-PLYMOUTH) |
| Manufacturer Street | 5050 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55442 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVISOR? HD GRID MAPPING CATHETER, SENSOR ENABLED? |
| Generic Name | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING |
| Product Code | DRF |
| Date Received | 2020-03-16 |
| Model Number | D-AVHD-DF16 |
| Catalog Number | D-AVHD-DF16 |
| Lot Number | 7050666 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL |
| Manufacturer Address | 5050 NATHAN LANE NORTH PLYMOUTH MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-16 |