MAUDE Adverse Event Report: CORDIS CASHEL SABER 5MM30CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number 48005030X

Device Problem Structural Problem (2506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2018

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot (17711129) presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, a saber pta (5mm30cm 150) balloon catheter proximal marker band appears to be a bit distal to the edge of the balloon.There was no reported patient injury.The target lesion was the superficial femoral artery (sfa).The vessel level of calcification and tortuosity is mild.The vessel level of stenosis is 80%.The device was not used for a chronic total occlusion (cto) lesion.The device was stored and handled per the instructions for use (ifu).There were no anomalies noted to the device when it was taken out of the packaging.There was no difficulty removing the product from the hoop.There was no difficulty removing the protective balloon cover.The product was prepped properly according to the ifu.The device was prep normally.The catheter was not re-shaped by the user.There were no kinks or other damages noted prior to inserting the product into the patient.The catheter tip was visible on fluoro throughout the procedure.There was no difficulty tracking the catheter through the vessel or lesion.The catheter was not torqued against resistance.All marker bands were accounted for after the catheter was removed from the patient.There was no kink/bend noted in the area of separation.The device will be return for analysis.

Manufacturer Narrative

As reported, a 5x300mm 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter proximal marker band appears to be a bit distal to the edge of the balloon.There was no reported patient injury.The target lesion was the superficial femoral artery (sfa).The vessel level of calcification and tortuosity is mild.The vessel level of stenosis is 80%.The device was not used for a chronic total occlusion (cto) lesion.The device was stored and handled per the instructions for use (ifu).There were no anomalies noted to the device when it was taken out of the packaging.There was no difficulty removing the product from the hoop.There was no difficulty removing the protective balloon cover.The product was prepped properly according to the ifu.The device was prep normally.The catheter was not re-shaped by the user.There were no kinks or other damages noted prior to inserting the product into the patient.The catheter tip was visible on fluoroscopy throughout the procedure.There was no difficulty tracking the catheter through the vessel or lesion.The catheter was not torqued against resistance.All marker bands were accounted for after the catheter was removed from the patient.There was no kink/bend noted in an area of separation.A non-sterile saber 5mm30cm 150 was received coiled inside a plastic bag.Balloon was already inflated.No damages or anomalies were observed.Dimensional analysis was performed to verify the correct distance between distal and proximal marker bands.Measurement was compared against the specification, and the result was found within specification.A device history record (dhr) review of lot 17711129 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿marker band offset/out of position¿ was not be confirmed since the marker bands were found to be within specification.The exact cause of the issue experienced could not be conclusively determined.Based on the limited information available for review, it is not possible to determine what factors may have contributed to the reported issue.According to the instructions for use, which is not intended as a mitigation, ¿radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement.For balloon lengths greater than or equal to 100mm, the distal section will have one (1) marker band and proximal section will consist of two (2) adjacent marker bands.For balloon lengths less than 100mm, the distal and proximal section will have each one (1) marker band.Prior to angioplasty, the catheter should be examined to verify functionality and ensure that its size and shape are suitable for the specific procedure for which it is to be used.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.¿ neither the dhr review, nor the product analysis suggests that the reported issue could be related to the manufacturing process of the unit.Therefore, no corrective actions will be taken at this time.

• Brand Name: SABER 5MM30CM 150
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 7762035
• MDR Text Key: 116400387
• Report Number: 9616099-2018-02293
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K971010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 48005030X
• Device Lot Number: 17711129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2018
• Date Manufacturer Received: 07/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1