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

Catalog Number UNKSAVVY

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

Patient Problem Rupture (2208)

Event Date 01/31/2010

Event Type  Injury  

Manufacturer Narrative

Abdelhamid, m., davies, r., rai, s., hopkins, j., duddy, m., & vohra, r.(2010).Below-the-ankle angioplasty is a feasible and effective intervention for critical leg ischaemia.European journal of vascular and endovascular surgery, 39(6), 762-768.Doi:10.1016/j.Ejvs.2010.01.027.In the literature article by abdelhamid, m., davies, r., rai, s., hopkins, j., duddy, m., & vohra, r.(2010).Below-the-ankle angioplasty is a feasible and effective intervention for critical leg ischaemia.European journal of vascular and endovascular surgery, 39(6), 762-768.Doi:10.1016/j.Ejvs.2010.01.027; rupture of the treated artery occurred in one case, which did not require surgical intervention.The patient had critical limb ischemia.The procedure was a below the knee angioplasty in which a savvy balloon catheter was used to dilate the artery.The product was not returned for analysis.No lot number was provided therefore a product history record (phr) review could not be generated.There is no additional information regarding patient, lesion or procedural characteristics regarding this event.With the limited amount of information available and without the return of the product or films of the procedure, it is not possible to draw a clinical conclusion between the device and the event.However, vessel characteristics and procedural factors may have contributed to the reported event.Vessel damage, such as an arterial rupture, is a known potential adverse event associated with any procedure in which devices are introduced into the patient.Angioplasty of atherosclerotic vessels using balloon catheters have the potential to cause rupture or tearing of the target vessel.According to the instructions for use ¿balloon pressure should not exceed the rated burst pressure.The rated burst pressure is based on the result of in vitro testing.At least 99.9% of the balloons (with a 95% confidence level) will not burst at or below their rated burst pressure.Use of a pressure monitoring device is recommended to prevent over pressurization.Use only the recommended balloon inflation medium.Never use air or any gaseous medium to inflate the balloon.Prior to angioplasty, the catheter should be examined to verify functionality and ensure that its size and shape are suitable for the specified procedure for which the device will be used.¿ as no lot number, catalogue code or other product information was supplied a phr could not be completed.The information available does not suggest a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.

Event Description

As reported in the literature by abdelhamid, m., davies, r., rai, s., hopkins, j., duddy, m., & vohra, r.(2010).Below-the-ankle angioplasty is a feasible and effective intervention for critical leg ischaemia.European journal of vascular and endovascular surgery, 39(6), 762-768.Doi:10.1016/j.Ejvs.2010.01.027; rupture of the treated artery occurred in one case, which did not require surgical intervention.The patient had critical limb ischemia.The procedure was a below the knee angioplasty in which a savvy balloon catheter was used to dilate the artery.

• Brand Name: UNKSAVVY
• 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: 8332840
• MDR Text Key: 135993656
• Report Number: 9616099-2019-02708
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K971010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKSAVVY
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/15/2019
• Initial Date FDA Received: 02/12/2019
• 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
• Patient Outcome(s): Hospitalization; Required Intervention; Disability