MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-03 for UNKNOWN manufactured by Cook Inc.
[107326469]
Blank fields on this form indicate the information is unknown, or unavailable. Common name & product code = unavailable as the device lot number, rpn, and gpn are unknown. (b)(4). Pma/510(k) number = unavailable as the device lot number, rpn, and gpn are unknown. Pma/510(k) number = pre-amendment. This report includes information known at this time. A follow-up report will be submitted should additional relevant information become available. Zellner et. Al, (2011), sterile radial artery granuloma after transradial cardiac catheterization, (12) pp. 187-189, elsevier, information retrieved from: doi:10. 1016/j. Carrev. 2010. 06. 003 - attachment: [zellner article_. Pdf].
Patient Sequence No: 1, Text Type: N, H10
[107326470]
A journal article titled "sterile radial artery granuloma after transradial cardiac catheterization" was reviewed: the study author reported a 59-year-old woman with a history of systemic lupus erythematosis, hypertension, and hyperlipidemia was referred for evaluation of worsening shortness of breath and dyspnea on exertion. Examination of her cardiovascular and pulmonary systems was normal. Chest x-ray and electrocardiogram results were normal. Echocardiogram revealed elevated pulmonary artery pressure and borderline left ventricular systolic function. Computed tomography of the chest showed no interstitial lung disease, ventilation/perfusion scintigraphy excluded pulmonary thromboembolic disease, and a cardiac catheterization was requested for further evaluation. Right heart catheterization revealed normal right atrial and pulmonary capillary wedge pressures, right ventricular pressure of 34/6 mmhg, and pulmonary artery (pa) pressure of 34/12 (mean 20) mmhg at rest. Pulmonary vascular resistance was 2. 5 wood units. Supine bicycle exercise was performed for 8 min, achieving 5. 8 mets; pa pressure rose to 67/24 (mean 42) mmhg, meeting criteria for exercise-induced pulmonary hypertension. Left heart catheterization was performed via the right radial artery using a 5-french hydrophilic-coated sheath (cook, inc. , bloomington, in, usa). This revealed no significant angiographic coronary artery disease and normal left ventricular end-diastolic pressure. Medications given were intravenous heparin 3000 u, intra-arterial verapamil 3 mg, and intra-arterial nitroglycerin 200? G. After removal of left heart catheters, the sheath was removed without difficulty. Hemostasis at the arterial puncture site was achieved with a hemoband for 2 h. The procedure was uncomplicated and the patient was discharged the same day. Eight days after the cardiac catheterization, the patient presented to her physician complaining of redness, swelling, and tenderness at the arterial access site. Antibiotics were prescribed with no change in clinical status. Ultrasound demonstrated a mass at the radial artery site with no flow in the mass, but with normal flow through the radial artery. This was thought to reflect a thrombosed pseudoaneurysm. A total of 18 days after the procedure, because of persistent redness and swelling, the patient was referred to a vascular surgeon for a presumed diagnosis of infected, thrombosed pseudoaneurysm of the radial artery. White blood cell count was normal, the patient was afebrile, and blood cultures were negative. She was brought to the operating room, where her radial artery was resected. Pathology revealed the diagnosis. There was amorphous grey material in the vessel wall and the extravascular space, and associated with this was granulomatous inflammation consistent with a foreign body reaction to the hydrophilic coating on the sheath. No pseudoaneurysm was identified. No infectious organisms or pus was seen. Per the author, granuloma, or foreign body reaction, to hydrophilic coated sheaths used for transradial cardiac catheterization is a benign and self-limiting disorder. It usually presents 1? 3 weeks after the procedure with redness, swelling, and tenderness at the arterial access site. Our case is similar to others in the literature, presenting with the classic symptoms of wrist discomfort, redness, and a lump over the radial access site. Like other cases in the literature, it was confused with infection and was treated as such.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-01355 |
| MDR Report Key | 7483429 |
| Date Received | 2018-05-03 |
| Date of Report | 2018-07-27 |
| Date of Event | 2010-06-11 |
| Date Mfgr Received | 2018-07-20 |
| Date Added to Maude | 2018-05-03 |
| 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 | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UNKNOWN |
| Product Code | GCE |
| Date Received | 2018-05-03 |
| Catalog Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-05-03 |