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 2020-03-19 for LANGSTON 5540 manufactured by Vascular Solutions, Llc.
[188825747]
Langston v2 catheter was returned for evaluation. The investigation is in progress; when results or further information is received a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[188825748]
As reported: cut down axillary tavr. Used the langston in the right radial artery instead of getting any groin artery access. We got radial access to use a langston for injections and pressures. We took one injection of the ao. We went to reposition the catheter with the j tip wire. The physician realized the wire was not coming out of the pigtail of the catheter. The catheter was removed from the arm via over the wire. When catheter was pulled out the inner lumen was still in the arm. All of langston was removed with no injury or issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134812-2020-00027 |
| MDR Report Key | 9856735 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2019-08-22 |
| Date Added to Maude | 2020-03-19 |
| 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 | MS. MARY HAUFEK |
| Manufacturer Street | 6464 SYCAMORE COURT NORTH |
| Manufacturer City | MINNEAPOLIS, MN |
| Manufacturer Country | US |
| Manufacturer Phone | 6564230 |
| Manufacturer G1 | VASCULAR SOLUTIONS, LLC |
| Manufacturer Street | 6464 SYCAMORE COURT NORTH |
| Manufacturer City | MINNEAPOLIS, MN |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LANGSTON |
| Generic Name | DUEL LUMEN |
| Product Code | DQO |
| Date Received | 2020-03-19 |
| Returned To Mfg | 2020-03-10 |
| Model Number | 5540 |
| Catalog Number | 5540 |
| Lot Number | 655128 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VASCULAR SOLUTIONS, LLC |
| Manufacturer Address | 6464 SYCAMORE COURT NORTH MINNEAPOLIS, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-19 |