MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2019-01-11 for NUDEL 423 DEL025 manufactured by Numed, Inc..
[132779949]
The report from the hospital stated that there was no definite evidence of device malfunction. A physician stated in an email that "the iliac artery went into spasm and that may have caused the problem. " the device was not returned to numed, so "an" a physical examination of the device was not possible. A final qc check is performed on 100% of the devices before they leave numed. A review of the production records show that there were no issues with the devices that were released for distribution. Taken from the nudel ifu: contraindications: patients too small to allow safe delivery of the stent without compromise to the systemic artery used for delivery. Warnings: over-stretching of the artery may result in rupture or aneurysm formation. Do not advance the guidewire, the combined balloon catheter in the sheath, or any other component if resistance is encountered without first determining the cause and taking remedial action.
Patient Sequence No: 1, Text Type: N, H10
[132779950]
As per the report from the physician / foreign distributor - "life-threatening vascular injury related to attempted transcatheter stenting of aortic coarctation using the nudel system (14f, 4. 5cm stent, 18mm balloon). Iliac artery dissection/rupture whilst advancing the 14f sheath. Vessel salvaged using multiple covered stents. " "emergency stenting of descending aorta, bilateral iliac arteries. Vascular surgical reconstruction of ilio-femoral artery. Urgent laparostomy for abdominal compartment syndrome. Renal replacement therapy. " " no definite evidence of device malfunction. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1318694-2019-00001 |
| MDR Report Key | 8239284 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2019-01-11 |
| Date of Report | 2019-01-10 |
| Date of Event | 2018-12-18 |
| Date Mfgr Received | 2018-12-20 |
| Device Manufacturer Date | 2017-06-29 |
| Date Added to Maude | 2019-01-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. NICHELLE LAFLESH |
| Manufacturer Street | 2880 MAIN STREET |
| Manufacturer City | HOPKINTON NY 12965 |
| Manufacturer Country | US |
| Manufacturer Postal | 12965 |
| Manufacturer Phone | 3153284491 |
| Manufacturer G1 | NUMED, INC. |
| Manufacturer Street | 2880 MAIN STREET |
| Manufacturer City | HOPKINTON NY 12965 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 12965 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUDEL |
| Generic Name | AORTIC STENT DELIVERY SYSTEM |
| Product Code | PNF |
| Date Received | 2019-01-11 |
| Model Number | 423 |
| Catalog Number | DEL025 |
| Lot Number | DEL-0135 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NUMED, INC. |
| Manufacturer Address | 2880 MAIN STREET HOPKINTON NY 12965 US 12965 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2019-01-11 |