MAUDE Adverse Event Report: CORDIS CORPORATION SABER PTA DILATATION CATHETER; PTA CATHETERS (LIT)

Catalog Number 48008004S

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2016

Event Type  Injury  

Manufacturer Narrative

Concomitant products: sheath introducer 6f the product is not available for evaluation and testing.Additional information will be submitted within 30 days of receipt.

Event Description

During a percutaneous transluminal angioplasty to the fistula, it was reported, after a saber balloon had been inflated, the balloon broke up due to the hard calcified plaque.The device was extracted by using a 6f introducer.The surgeon noticed that the balloon detached from the catheter and it remained in the artery.The balloon was dragged with another balloon in the venous part of the fistula and it was left there.No consequence for the patient was reported.The patient's current status is good.There was no difficulty removing the product from the packaging.The device was prepped normally, maintaining negative pressure.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve.There was ¿a bit of¿ resistance/friction while inserting the balloon through the.018 v18 boston scientific guidewire.There was no difficulty advancing the balloon catheter through the vessel.There was no difficulty with the saber balloon crossing the lesion.The balloon catheter was in an acute bend along the fistula¿s curve.The balloon did inflate normally.The balloon did not deflate normally as it was broken.The balloon was not caught in the lesion or in a deployed stent.The vessel was not tortuous and it was 80% stenosed.Procedural cd is not available for review.

Manufacturer Narrative

Complaint conclusion: during a percutaneous transluminal angioplasty to a fistula, after a saber balloon had been inflated, the balloon broke up due to the hard calcified plaque.The device was extracted by using a 6f introducer.The surgeon noticed that the balloon detached from the catheter and it remained in the artery.The balloon was dragged with another balloon in the venous part of the fistula and it was left there.No consequence for the patient was reported.The patient¿s current status is good.The vessel was not tortuous but it was 80% stenosed.There was no difficulty removing the product from the packaging.The device was prepped normally, maintaining negative pressure.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve.There was ¿a bit of¿ resistance/friction while inserting the balloon through the 0.018¿ v18 boston scientific guidewire.There was no difficulty advancing the balloon catheter through the vessel.There was no difficulty with the saber balloon crossing the lesion.The balloon catheter was in an acute bend along the fistula¿s curve.The balloon did inflate normally.The balloon did not deflate normally as it was broken.The balloon was not caught in the lesion or in a deployed stent.The product was not returned for analysis.A device history record (dhr) review of lot 17052554 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon separated-in-patient (peripheral)¿ and ¿pta system withdrawal difficulty-from vessel¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics of a rate of stenosis of 80% may have contributed to the reported event.According to the instructions for use ¿prior to angioplasty, the catheter should be examined to verify functionality and integrity, and ensure that its size and shape are suitable for the specific procedure for which it is to be used.Do not use if product damage is suspected or evident.Pressure in excess of the rated burst pressure can cause balloon rupture and potential inability to withdraw the catheter through the introducer sheath.Balloon rupture can cause vessel damage and the need for additional intervention.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 resistance before proceeding.If resistance is felt upon removal, then the balloon, guidewire and the sheath should be removed together as a unit, particularly if balloon rupture or leakage is known or suspected.Proper functioning of the catheter depends on its integrity.Care should be used when handling the catheter.Damage may result from kinking, stretching, or forceful wiping of the catheter.Forceful handling can result in catheter separation and the subsequent need to use a snare or other medical interventional techniques to retrieve the pieces.Always verify integrity of the catheter after removal.Deflate the balloon by pulling vacuum on the inflation syringe or inflation device.Remove the vacuum (do not apply pressure) and carefully withdraw and remove the catheter.Note: gentle counterclockwise rotation of the balloon may ease withdrawal from the sheath or from the percutaneous entry site.If the balloon cannot be withdrawn through the sheath, withdraw the catheter and sheath as a unit.¿ neither the dhr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken.

• Brand Name: SABER PTA DILATATION CATHETER
• Type of Device: PTA CATHETERS (LIT)
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL
• Manufacturer Contact: cecil navajas ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 7863133880
• MDR Report Key: 5418950
• MDR Text Key: 37780883
• Report Number: 9616099-2016-00066
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K971010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: 48008004S
• Device Lot Number: 17052554
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2016
• Date Device Manufactured: 07/22/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention