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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL SABER RX5MM30CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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CORDIS CASHEL SABER RX5MM30CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 51005030L
Device Problem Structural Problem (2506)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/02/2019
Event Type  malfunction  
Manufacturer Narrative
During use of the saber percutaneous transluminal angioplasty (pta) balloon catheter for dilation, the marker seemed to be in out of position about one to two cm from the balloon.There was no patient injury.The doctor decided not to inflate because it was dangerous.Therefore, the balloon was removed from the patient and the procedure finished.The device was prepped according to the instruction for use (ifu).There were no difficulties removing the product from the hoop, the protective balloon cover, the stylet or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product the product into the patient.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve, the guide catheter, or through the vessel.The catheter has been in an acute bend.The product was removed intact (all marker bands accounted for) from the patient.The product was returned for analysis.One non-sterile saber rx 5mm x 30cm 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 82161196 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/preventive action will be taken at this time.
 
Event Description
During use of the saber percutaneous transluminal angioplasty (pta) balloon catheter for dilation, the marker seemed to be in out of position about 1 to 2 cm from the balloon.There was no patient injury.The doctor decided not to inflate because it was dangerous.Therefore, the balloon was removed from the patient and the procedure finished.The device was prepped according to the instruction for use (ifu).There were no difficulties removing the product from the hoop, the protective balloon cover, the stylet or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product the product into the patient.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve, the guide catheter, or through the vessel.The catheter has been in an acute bend.The product removed intact (all marker bands accounted for) from the patient.The device will be returned for analysis and the customer requested the final letter.No other information was provided.
 
Manufacturer Narrative
During use of the saber percutaneous transluminal angioplasty (pta) balloon catheter for dilation, the marker seemed to be in out of position about one to two cm from the balloon.There was no patient injury.The doctor decided not to inflate because it was dangerous.Therefore, the balloon was removed from the patient and the procedure finished.The device was prepped according to the instruction for use (ifu).There were no difficulties removing the product from the hoop, the protective balloon cover, the stylet or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product the product into the patient.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve, the guide catheter, or through the vessel.The catheter has been in an acute bend.The product was removed intact (all marker bands accounted for) from the patient.The product was returned for analysis.One non-sterile saber rx 5mm x 30cm 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 82161196 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/preventive action will be taken at this time.
 
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Brand Name
SABER RX5MM30CM155
Type of Device
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, co. tipperary
EI 
MDR Report Key8856674
MDR Text Key197281752
Report Number9616099-2019-03116
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 08/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/31/2021
Device Model Number51005030L
Device Catalogue Number51005030L
Device Lot Number82161196
Was Device Available for Evaluation? Yes
Date Manufacturer Received07/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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