MAUDE Adverse Event Report: CORDIS CASHEL SABER RX5MM10CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number 51005010L

Device Problem Structural Problem (2506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/17/2019

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot (17565912) 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 rx pta balloon catheter (5mm10cm155) was attempted to be used during procedure; however, it was confirmed that the position of the proximal markers on the balloon proxy side was largely shifted.There was no reported patient injury.The lesion was the superficial femoral artery.The vessel level of angulation, calcification and tortuosity is none.The device was being used for treatment of a chronic total occlusion.Initially, an ipsilateral approach was made.The device damaged was noted during use.The device was stored and handled per the instructions for use (ifu).There was no damage noted to the package.The integrity of the sterile pouch was not compromised.There were no anomalies noted to the device when it was taken out of the packaging.There were no damages noted prior to inserting the product into the patient.The device was prepped according to instructions for use (ifu).The device was prep normally.The device was used in-patient.There was no difficulty advancing the balloon catheter through the vessel.The catheter was not torqued against resistance.There was no excessive torque used during advancement or delivery of the device.There was no unusual force used at any time during the procedure.There were no kink/bent noted after device was removed from patient.The device was removed intact (in one piece) from the patient.There was no other type of malfunction noted on the device.The device was removed, and the procedure was completed.The device will be returned for analysis.

Manufacturer Narrative

A saber rx percutaneous transluminal angioplasty (pta) balloon catheter (5mm10cm155) was attempted to be used during procedure; however, it was confirmed that the position of the proximal markers on the balloon proxy side was largely shifted.There was no reported patient injury.The lesion was the superficial femoral artery.The vessel level of angulation, calcification and tortuosity is none.The device was being used for treatment of a chronic total occlusion.Initially, an ipsilateral approach was made.The device damaged was noted during use.The device was stored and handled per the instructions for use (ifu).There was no damage noted to the package.The integrity of the sterile pouch was not compromised.There were no anomalies noted to the device when it was taken out of the packaging or prior to inserting the product into the patient.The device was prepped normally according to instructions for use (ifu).The device was used in-patient.There was no difficulty advancing the balloon catheter through the vessel.The catheter was not torqued against resistance.There was no excessive torque used during advancement or delivery of the device.There was no unusual force used at any time during the procedure.There was no kink/bent noted after device was removed from patient.The device was removed intact (in one piece) from the patient and the procedure was completed.There was no other type of malfunction noted on the device.The product was returned for analysis.One non-sterile saber rx 5mm x 10cm x 155cm was returned.Per visual analysis, the balloon was coiled inside a plastic bag and seems to have been inflated and deflated.The marker bands were inspected, and no damages or anomalies were observed.A dimensional analysis was performed to verify the correct distance between the distal and proximal marker bands and the distance between the distal/proximal marker bands and balloon shoulders.All measurements were found to be within specification.A product history record (phr) review of lot 17565912 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported "marker band-balloon catheters-offset/out of position - in-patient" was not confirmed during analysis of the returned device.Dimensional analysis revealed the distance between the distal and proximal marker bands, and the distal/proximal marker bands and balloon shoulders were all were found to be within specification.However, it was determined that although the device was within specification, variation within the specification allowed some differences in location of the markers in relation to the balloon shoulders.According to the device description in the safety information in the instructions for use ¿the cordis saber percutaneous transluminal angioplasty (pta) dilatation catheter is a catheter with a distal inflatable balloon.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.The catheter tip is tapered to ease entry into peripheral arteries and to facilitate the crossing of tight stenoses.The radiopaque marker bands (the length between the outer edge of most proximal to the outer edge of most distal marker band) indicate the stated nominal length of the balloon.¿ the product analysis suggests that the event experienced by the customer could be related to the manufacturing process.Therefore, a corrective or preventive action will be taken at this time.

• Brand Name: SABER RX5MM10CM155
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co.; tipperary ; EI
• MDR Report Key: 8862158
• MDR Text Key: 197292054
• Report Number: 9616099-2019-03120
• 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
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 51005010L
• Device Lot Number: 17565912
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1