MAUDE Adverse Event Report: CORDIS CASHEL PTA SAVVY 80CM 6X2; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 435602S

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/09/2018

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, a savvy balloon catheter (pta savvy 80cm 6x2) frayed apart in the patient and the balloon tip was left behind on the guidewire in the iliac artery at the level of the diaphragm.It was reported that the left femoral artery was too small for the dilation balloon to be removed.Surgery was consulted but felt that the risk of cutdown was too high to proceed with the patient on extracorporeal membrane oxygenation (ecmo).There was no apparent further compromise of pre-existing poor flow.It was planned that, if the patient were able to be removed from ecmo, the physician would retrieve the balloon catheter tip through the sheath when the arterial cannula was removed.The patient had hypoplastic left heart syndrome (hlhs) and was taken for a pediatric pulmonary artery angioplasty, aortogram, peripheral stent placement, and peripheral angioplasty.It was reported that the patient had large thrombus in both pulmonary arteries and severe stenosis of the bt shunt that was placed during a norwood procedure on day 13 of life.Due to the patient's multi-organ dysfunction, a decision was made to withdraw care.The patient expired post withdrawal of ecmo support.

Manufacturer Narrative

Complaint conclusion: as reported, a 6 x 20mm 80cm savvy balloon catheter (bc) frayed apart in the patient and the balloon tip was left behind on the guidewire in the iliac artery at the level of the patient¿s diaphragm.It was reported that the patient presented to the procedure with a large thrombus in both pulmonary arteries and severe stenosis of the blalock¿taussig (bt) shunt that was placed during a norwood procedure on 13th day of life.The patient had hypoplastic left heart syndrome (hlhs) and was taken for a pediatric pulmonary artery angioplasty, aortogram, peripheral stent placement, and peripheral angioplasty.The patient was also on extracorporeal membrane oxygenation (ecmo) support.However, during treatment with the 6 x 20mm savvy bc, it was reported that the left femoral artery was too small for the dilation balloon to be removed.The device frayed apart in the patient and the balloon tip was left behind on the guidewire.Surgery was consulted but felt that the risk of cutdown was too high to proceed with the patient on ecmo.There was no apparent further compromise of the pre-existing poor flow.It was planned that, if the patient were able to be removed from ecmo, the physician would retrieve the balloon catheter tip through the sheath when the arterial cannula was removed.However, due to the patient's multi-organ dysfunction, a decision was made to withdraw care.The patient expired post-withdrawal of ecmo support.The device was not returned for analysis.A device history record (dhr) review of lot 17702074 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿pta/ptca system withdrawal difficulty from vessel¿ and ¿distal tip separated in patient¿ could not be confirmed as the device was not returned for analysis, and procedural images were not provided.The exact cause of the issue experienced could not be determined.However, based on the information available for review, patient factors (pediatric patient with left femoral artery too small for the balloon to be removed) most likely contributed to the withdrawal difficulty experienced, and handling of the balloon catheter due to the withdrawal difficulty may have contributed to the separated tip reported.Hypoplastic left heart syndrome (hlhs) is a congenital heart defect in which the left side of the heart does not develop correctly.The left ventricle, mitral valves and aortic valves are affected and result in poor oxygenated blood flow from the heart to the body.A common treatment for this condition is the norwood procedure in which a new aorta is created from the right ventricle, and a bt shunt (which connects the aorta vessel to the pulmonary veins to receive oxygen) is created.In this case, the patient needed treatment due to a severe stenosis of the bt shunt and was on ecmo due to low oxygenation.The patient¿s artificial access to oxygenated blood was compromised; which can result in multi-organ dysfunction/failure from lack of oxygen-rich blood.It was decided to withdraw care due to the critical condition of the patient and the inability to tolerate a cut-down of the access site to remove the pta catheter that was too large for the patient.According to the information on patient safety in the instructions for use (ifu), ¿when the catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation.Do not advance or retract the catheter unless the balloon is fully deflated under vacuum.If resistance is met during manipulation, determine the cause of the resistance before proceeding.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.The minimal acceptable sheath french size is printed on the package label.Do not attempt to pass the pta catheter through a smaller size sheath introducer than indicated on the label.¿ additionally, the ifu states that the device is intended for balloon dilatation of lesions in peripheral arteries (iliac, renal, popliteal, infra-popliteal, femoral, and ilio-femoral) and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae.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.Neither the dhr review nor the information available for review suggests that the reported failure/event could be related to the manufacturing process of the unit.Therefore, no corrective actions will be taken at this time.

• Brand Name: PTA SAVVY 80CM 6X2
• 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. tippereray; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 8086517
• MDR Text Key: 127852143
• Report Number: 9616099-2018-02544
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: 435602S
• Device Catalogue Number: 435602S
• Device Lot Number: 17702074
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2017
• 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): Death
• Patient Weight: 4