MAUDE Adverse Event Report: CORDIS CASHEL SABER RX4MM30CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 51004030L

Device Problem Structural Problem (2506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/14/2019

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 82159348 has not yet been performed.However, it will be submitted within 30 days of receipt.This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, a saber rx pta balloon catheter was delivered and inflated as a pre-dilatation, however, the marker seemed to be out of position.There was no reported patient injury.The procedure was completed but the physician requested an analysis report of this balloon catheter and the cause of this incident.This was a superficial femoral artery (sfa) case.

Manufacturer Narrative

The device was stored and handled per the instructions for use (ifu).There was no difficulty removing the stylet or any of the sterile packaging components, hoop or protective balloon cover.The device was prepped per the ifu.The device prepped normally.There were no anomalies noted during or after the device was prepped.The same indeflator was used successfully with other devices.There was no difficulty tracking the catheter through the vessel or lesion.The catheter was not re-shaped by the user.There were no kink/bent conditions noted after the device was removed from the patient.There was no unusual force used at any time during the procedure.Corrected data: initial reporter name and address.A saber rx percutaneous transluminal angioplasty (pta) balloon catheter was delivered and inflated as a pre-dilatation; however, the marker seemed to be out of position.There was no reported patient injury.The procedure was completed, but the physician requested an analysis report of this balloon catheter and the cause of this incident.This was a superficial femoral artery (sfa) case.There was no difficulty tracking the catheter through the vessel or lesion.The catheter was not re-shaped by the user.There were no kink/bent conditions noted after the device was removed from the patient.There was no unusual force used at any time during the procedure.The device was stored, handled, and prepped normally per the instructions for use (ifu).There was no difficulty removing the stylet or any of the sterile packaging components, hoop or protective balloon cover.There were no anomalies noted during or after the device was prepped.The same indeflator was used successfully with other devices.The product was returned for analysis.One non-sterile saber rx 4mm 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 the proximal marker bands.The measurement was found within specification.A product history record (phr) review of lot 82159348 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.Analysis revealed the distance between the distal and the proximal marker bands was measured and it was found within specification.The exact cause could not be determined.It is likely procedural and handling factors may have contributed to the reported event.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.¿ neither the phr nor the information available suggests a manufacturing related cause for the reported event; however, a risk assessment has been opened for this issue.

Manufacturer Narrative

A saber rx percutaneous transluminal angioplasty (pta) balloon catheter was delivered and inflated as a pre-dilatation; however, the marker seemed to be out of position.There was no reported patient injury.The procedure was completed, but the physician requested an analysis report of this balloon catheter and the cause of this incident.This was a superficial femoral artery (sfa) case.There was no difficulty tracking the catheter through the vessel or lesion.The catheter was not re-shaped by the user.There were no kink/bent conditions noted after the device was removed from the patient.There was no unusual force used at any time during the procedure.The device was stored, handled, and prepped normally per the instructions for use (ifu).There was no difficulty removing the stylet or any of the sterile packaging components, hoop or protective balloon cover.There were no anomalies noted during or after the device was prepped.The same indeflator was used successfully with other devices.The product was returned for analysis.One non-sterile saber rx 4mm 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 82159348 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.The exact cause of the reported event could not be determined.It is likely procedural and handling factors may have contributed to the reported event.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.¿ neither the phr nor the information available suggests a manufacturing related cause for the reported event; however, a risk assessment has been opened for this issue.

• Brand Name: SABER RX4MM30CM155
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 8511291
• MDR Text Key: 145116796
• Report Number: 9616099-2019-02851
• 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,Followup
• Report Date: 06/17/2019

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: 08/31/2021
• Device Model Number: 51004030L
• Device Catalogue Number: 51004030L
• Device Lot Number: 82159348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Initial Date Manufacturer Received: 03/14/2019
• Initial Date FDA Received: 04/12/2019
• Supplement Dates Manufacturer Received: 04/22/2019; 05/31/2019
• Supplement Dates FDA Received: 05/16/2019; 06/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1