MAUDE Adverse Event Report: CORDIS CASHEL UNKSAVVY435; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number UNKSAVVY435

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 02/01/2008

Event Type  Injury  

Manufacturer Narrative

(b)(4).This article was found during a recent literature search of this device.Please note that patient specific details (demographics, medical history, and reason for intervention) are not available.The device is an unknown savvy balloon catheter and the catalog and lot numbers are not available.Kimiagar et al,.(2008).Carotid artery stenting in high risk patients with carotid artery stenosis not eligible for endarterectomy: clinical outcome after 5 years., imaj ;10:121¿124.As reported by kimiagar et al., (2008), carotid artery stenting in high risk patients with carotid artery stenosis not eligible for endarterectomy: clinical outcome after 5 years., imaj ;10:121¿124; one procedural failure occurred in which the patient underwent urgent endarterectomy.The procedure was a carotid artery stenting that was performed with a low profile 4-20mm savvy balloon catheter which was used for pre-dilatation after administration of 0.6 mg atropine and then a stent was deployed from the internal to the common carotid.The device was not returned for analysis.Additionally, as the sterile lot number was not available, device history record (dhr) reviews could not be performed.Given the limited information provided, the reported event ¿endarterectomy¿ could not be confirmed and the exact root cause could not be determined.A carotid endarterectomy is a surgical operation in which a plaque is removed from the carotid artery.Plaques are areas of fatty build-up in blood vessels.Vessel characteristics and procedural/handling factors may have contributed to the reported event.Additionally, usage of the product other than that indicated in the product's instructions for use (ifu) may involve additional risks not described in the labeling.Without a lot number to conduct a dhr review, it is not possible to determine if the reported failure could be related to the manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.

Event Description

As reported by kimiagar et al., (2008), carotid artery stenting in high risk patients with carotid artery stenosis not eligible for endarterectomy: clinical outcome after 5 years., imaj ;10:121¿124; one procedural failure occurred in which the patient underwent urgent endarterectomy.The procedure was a carotid artery stenting that was performed with a low profile 4-20mm savvy balloon catheter which was used for pre-dilatation after administration of 0.6 mg atropine and then a stent was deployed from the internal to the common carotid.

• Brand Name: UNKSAVVY435
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 8326165
• MDR Text Key: 135730389
• Report Number: 9616099-2019-02701
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K971010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKSAVVY435
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: LONG 7 FR SUPER ARROW-FLEX SHEATH
• Patient Outcome(s): Life Threatening