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 2020-03-31 for TURNPIKE SPIRAL 5640 manufactured by Vascular Solutions, Llc.
[188826667]
The product was returned to vsi on 03/17/2020. Considering the recent events pertaining to covid-19, product inspection is paused and will not be evaluated at this time. The manufacturing record review was completed and no related nonconformances were found, supporting the device met material, assembly and performance. Specifications. A follow-up report will be submitted when product return investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
[188826668]
It was reported that the tip of the turnpike spiral broke off during a peripheral case. The turnpike spiral was being used in a cto lesion in a tortuous 4. 0 mm posterior tibial artery, however further blood flow was unsuccessful. The physician attempted to balloon the vessel but, was unsuccessful. Once the turnpike spiral was stuck, an attempt to balloon over the broken portion was unsuccessful. Later during attempt,a guidewire had also fractured off inside the sheath but was able to be retrieved. No further complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134812-2020-00030 |
| MDR Report Key | 9907583 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-03-03 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2019-05-11 |
| Date Added to Maude | 2020-03-31 |
| 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 | TURNPIKE SPIRAL |
| Generic Name | CATHETER |
| Product Code | DQY |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2020-03-17 |
| Model Number | 5640 |
| Lot Number | 647231 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-31 |