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 2020-02-14 for BRK? TRANSSEPTAL NEEDLE, 71 CM LENGTH 407200 manufactured by St. Jude Medical.
[183003163]
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.?
Patient Sequence No: 1, Text Type: N, H10
[183003164]
Related manufacturing ref: 3005334138-2020-00060. During the procedure, a dissection of the superior vena cava (svc) occurred. While preparing the introducer prior to patient insertion, a small obstruction was observed at the tip of the sheath while flushing. The brk needle was inserted through the sheath to clear the blockage but resistance was noted. Despite the obstruction and insertion difficulty, the introducer set and brk were inserted into the patient. Once positioned at the svc, the brk needle was attempted to be inserted through the introducer however resistance was felt. The needle was pushed through the introducer and dissected the svc. The introducer and needle were removed and ice confirmed a small bleed. The bleed resolved without any intervention. After the bleeding resolved the procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008452825-2020-00094 |
| MDR Report Key | 9714841 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-14 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-01-23 |
| Date Mfgr Received | 2020-03-11 |
| Device Manufacturer Date | 2019-07-19 |
| Date Added to Maude | 2020-02-14 |
| 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 |
| Manufacturer Street | PARQUE INDUSTRIAL, ZONA FRANCA COYOL S.A. EDIFICIO #44B, CALLE 0, AVENIDA 2, COYOL |
| Manufacturer City | ALAJUELA, COSTA RICA 1897-4050 |
| Manufacturer Country | CS |
| Manufacturer Postal Code | 1897-4050 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BRK? TRANSSEPTAL NEEDLE, 71 CM LENGTH |
| Generic Name | TROCAR |
| Product Code | DRC |
| Date Received | 2020-02-14 |
| Returned To Mfg | 2020-02-25 |
| Model Number | 407200 |
| Catalog Number | 407200 |
| Lot Number | 7096452 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL |
| Manufacturer Address | PARQUE INDUSTRIAL, ZONA FRANCA COYOL S.A. EDIFICIO #44B, CALLE 0, AVENIDA 2, COYOL ALAJUELA, COSTA RICA 1897-4050 CS 1897-4050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-14 |