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

Catalog Number 48003015S

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/26/2016

Event Type  malfunction  

Manufacturer Narrative

This device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, during use it was noticed the shaft was pierced at the base of the balloon of a saber 3mm 15cm 90 percutaneous transluminal angioplasty (pta) balloon catheter.They changed out the device and used another device (saber 3 mm) to complete the procedure successfully.There was no report of patient injury.The device will be returned for analysis.Details regarding patient anatomy include no tortuosity, severe calcification and 95% stenosis.There were no damages or anomalies noted to the device or packaging prior to use.There was no reported difficulty removing the product from the packaging.The product was stored, handled and prepped properly according to the instructions for use (ifu).There were no difficulties advancing the catheter through the sheath introducer.There were no difficulties advancing the catheter to the target lesion.The intended procedure was treatment of pre-occlusive popliteal stenosis, ischemia of level iv, right inferior member and leg arthritis.

Manufacturer Narrative

A review of the device history record revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.Additional information is pending and will be submitted in 30 days upon receipt.

Manufacturer Narrative

During use it was noticed that the shaft was pierced at the base of the balloon of a saber 3mm x 15cm 90cm percutaneous transluminal angioplasty (pta) balloon catheter.They changed out the device and used another device (saber 3 mm) to complete the procedure successfully.There was no report of patient injury.Details regarding patient anatomy include no tortuosity, severe calcification and 95% stenosis.There were no damages or anomalies noted to the device or packaging prior to use.There was no reported difficulty removing the product from the packaging.The product was stored, handled and prepped properly according to the instructions for use (ifu).There were no difficulties advancing the catheter through the sheath introducer.There were no difficulties advancing the catheter to the target lesion.The intended procedure was treatment of pre-occlusive popliteal stenosis, ischemia of level iv, right inferior member and leg arthritis.The device was not returned for analysis.A device history record (dhr) review of lot 17301817 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿body/shaft puncture/cut (peripheral)¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics of severe calcification and a rate of stenosis of 95% may have contributed to the reported event.According to the ifu ¿open the pouch, grasp the hub and gently take the catheter out.Do not use if inner package is opened or damaged.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.¿ 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: 5507802
• MDR Text Key: 40588969
• Report Number: 9616099-2016-00143
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K971010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: 48003015S
• Device Lot Number: 17301817
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2016
• Initial Date FDA Received: 03/17/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/08/2016; 04/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1