MAUDE Adverse Event Report: CORDIS CASHEL SABER RX7MM4CM155; PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER

Model Number N/A

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/24/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Concomitant medical products: guiding catheter (destination, terumoguidewire (cruise, asahi intecc).(b)(6).Please note that the device in this report is not sold in the us, however, it is similar to other cordis pta balloon catheters with the lit product code.The device was returned but the engineering report is pending.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

During use of a 7mm4cm155 saber rx percutaneous transluminal angioplasty (pta) balloon catheter, there was an abnormality felt with the marker which seemed to be far away and out of position.The doctor decided that it could not be used safely, and it will be returned for analysis.The balloon had been delivered and inflated as usual.The 75% occluded target lesion was the left external iliac artery with moderate vessel tortuosity.The access site was the inguinal region.The procedure being performed was a stent that was implanted in the left external iliac artery.The contrast media used was opaque injection, fuji pharma at a 1:1 contrast to saline ratio.An everest indeflator by medtronic was used in the procedure.The same indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve and no resistance/friction while inserting the balloon through the guide catheter.There was no difficulty advancing the balloon catheter through the vessel and no difficulty crossing the lesion.The catheter was never in an acute bend.The event occurred at the lesion.The balloon inflated normally was there was no difficulty removing it.

Manufacturer Narrative

During use of a 7mm x 4cm x 155cm saber rx percutaneous transluminal angioplasty (pta) balloon catheter, there was an abnormality felt with the marker which seemed to be far away and out of position.The doctor decided that it could not be used safely.The balloon had been delivered and inflated as usual.The seventy-five percent occluded target lesion was the left external iliac artery with moderate vessel tortuosity.The access site was the inguinal region.The procedure being performed was a stent implantation in the left external iliac artery.Non-cordis contrast media was used at a 1:1 contrast to saline ratio.A non-cordis indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or through the guide catheter.There was no difficulty advancing the balloon catheter through the vessel and no difficulty crossing the lesion.The catheter was never in an acute bend.The event occurred at the lesion and the balloon inflated normally with no difficulty upon removal.The product was returned for analysis.One non-sterile saber rx 7mm x 4cm 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 82160722 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.

• Brand Name: SABER RX7MM4CM155
• Type of Device: PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER
• Manufacturer (Section D): CORDIS CASHEL; cahir road; co, tipperaru; cashel ; EI
• MDR Report Key: 8708527
• MDR Text Key: 197610437
• Report Number: 9616099-2019-03025
• 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: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 51007004L
• Device Lot Number: 82160722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Date Manufacturer Received: 07/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE
• Patient Age: 76 YR