MAUDE Adverse Event Report: CORDIS CASHEL SABER RX6MM25CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 51006025L

Device Problem Structural Problem (2506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/27/2018

Event Type  malfunction  

Manufacturer Narrative

Additional information to include facility name: (b)(6) general hospital.The product was not returned for analysis.Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

During a in-stent re-stenosis, it was reported that the saber balloon catheter got lengthen 1cm or 2cm from the balloon marker when an attempt was made to inflate.There was no patient injury.The lesion was the superficial femoral artery.No other information was provided.

Manufacturer Narrative

This device was received for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Manufacturer Narrative

During an in-stent re-stenosis case, it was reported that the 6x250mm155cm saber rx balloon catheter got lengthen 1cm or 2cm from the balloon marker when an attempt was made to inflate.There was no patient injury.The lesion was the superficial femoral artery.No other information was provided.A non-sterile saber rx6mm25cm155 was received coiled inside a plastic bag.The balloon was received not inflated.Unknown solution residues were observed inside the balloon.No damages or anomalies were observed in the unit.A dimensional analysis was performed to verify the correct distance between distal and proximal marker bands.The measurement was compared against the drawing specification and the result was found within specification.A device history record (dhr) review of lot 17677325 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 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.

Manufacturer Narrative

During an in-stent re-stenosis procedure, it was reported that the 6x250mm 155cm saber balloon catheter got lengthen 1cm or 2cm from the balloon marker when an attempt was made to inflate.There was no patient injury.The lesion was the superficial femoral artery.No other information was provided.The device was not returned for analysis.A device history record (dhr) review of lot 17677325 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 in patient¿ could not be confirmed since the device was not returned for analysis.The exact cause of the issue experienced could not be 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 nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective/preventive action will be taken at this time.

• Brand Name: SABER RX6MM25CM155
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tipperary 0000 ; EI 0000
• MDR Report Key: 7813275
• MDR Text Key: 118256385
• Report Number: 9616099-2018-02341
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: 51006025L
• Device Catalogue Number: 51006025L
• Device Lot Number: 17677325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2018
• Date Manufacturer Received: 11/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1