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 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM 12673-03 manufactured by Abbott Vascular.
[189066898]
Event estimated date. The device was not returned for analysis. A review of the lot history record and complaint history of the reported lot could not be conducted, because the lot number was not provided. The reported difficulty and subsequent treatment appear to be related to an interaction of the device with patient anatomy or inability to maintain position/stability of the device during deployment due to circumstances of the procedure. Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device. The additional proglide devices are filed under separate medwatch report numbers.
Patient Sequence No: 1, Text Type: N, H10
[189066899]
It was reported as a general comment that an arteriotomy closure of common femoral arteries was attempted using proglide devices with a 6f sheath after interventional low leg procedures. Reportedly, when the plungers were removed, there was no suture for all proglide devices. Manual arterial compression was used to achieve hemostasis. There was no adverse patient sequela and no reported clinically significant delay in the procedures or therapies. The number of patients and procedures was not provided. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-03164 |
| MDR Report Key | 9907937 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2019-11-30 |
| Date Mfgr Received | 2020-03-09 |
| 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. LINDSEY BELL |
| Manufacturer Street | 26531 YNEZ RD. |
| Manufacturer City | TEMECULA CA 925914628 |
| Manufacturer Country | US |
| Manufacturer Postal | 925914628 |
| Manufacturer Phone | 9519143996 |
| Manufacturer G1 | ABBOTT VASCULAR, REG # 3005718570 |
| Manufacturer Street | CASHEL ROAD |
| Manufacturer City | CLONMEL TIPPERARY |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM |
| Generic Name | SUTURE MEDIATED CLOSURE |
| Product Code | MGB |
| Date Received | 2020-03-31 |
| Model Number | 12673-03 |
| Catalog Number | 12673-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT VASCULAR |
| Manufacturer Address | 26531 YNEZ RD. TEMECULA CA 925914628 US 925914628 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-31 |