MAUDE Adverse Event Report: CORDIS CASHEL SABER RX6MM10CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 51006010L

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/12/2020

Event Type  malfunction  

Manufacturer Narrative

This is one of two products involved with the reported event.The medical device reporting reference number for these events are 9616099-2020-03636.Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.This device was received for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Event Description

The 6mm 10cm 155 saber rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter (bc) was inserted but the pressure was not able to make it rise during its initial inflation; it was removed from the patient body and leakage from its shaft was confirmed.It was replaced with a new 2mm 30cm 155 saber rx pta balloon catheter; however, the same issue occurred.Therefore, it was replaced with a new saber pta and the procedure was completed.There was no reported patient injury.A non-cordis guidewire crossed the lesion.The lesion was below-the-knee.A contralateral approach was made from the right superficial femoral artery.The devices are expected to be returned for analysis.

Manufacturer Narrative

The 6mm x 10cm 155 saber rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter (bc) was inserted but the pressure was not able to make it rise during its initial inflation.The device was removed from the patient¿s body and a leakage from its shaft was confirmed.It was replaced with a new 2mm x 30cm 155 saber rx pta balloon catheter; however, the same issue occurred.Therefore, it was replaced with a new saber pta and the procedure was completed.There was no reported patient injury.A non-cordis guidewire crossed the lesion.The lesion was below-the-knee.A contralateral approach was made from the right superficial femoral artery.The device was returned for analysis.A non-sterile saber rx 6mm x 10cm x 155 was received for analysis coiled inside a plastic bag.Per visual analysis, the balloon appears to have been previously inflated.The unit was thoroughly inspected at naked eye and no other anomalies were observed.Per functional analysis, balloon inflation was performed.A lab inflator/deflator device was attached to the inflation lumen of unit and pressure applied.A leakage of water was observed on the body/shaft transition to balloon area.Per sem analysis on the unit¿s leakage observed during inflation test, results showed that the body/shaft leakage was caused by a rupture on the body/shaft transition to balloon area.The inner surface presented evidence of bulged/peeled off material near to the body/shaft transition to balloon rupture.The outer surface presented evidence of elongations and scratch marks adjacent to the body/shaft transition to balloon area.This type of damage is commonly caused during the interaction of the balloon material with a sharp object or mechanical damage.It is very likely that the same factors that caused the observed bulged/peeled off material, elongations and scratch marks on the body/shaft transition to balloon area surface most probably led to the ruptured condition found on the received device.It appears the balloon material near the rupture was torn with a sharp object from the outside of the balloon.No other anomalies were observed during the sem analysis.A product history record (phr) review of lot 82181109 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿body/shaft leakage - in-patient¿ and subsequent rupture on the body/shaft transition to balloon area was confirmed during functional analysis.The exact cause could not be determined.Device analysis for product 1 revealed the body/shaft leakage was caused by a rupture on the body/shaft transition to balloon area.The inner surface presented evidence of bulged/peeled off material near to the body/shaft transition to balloon rupture.The outer surface revealed elongations and scratch marks adjacent to the body/shaft transition to balloon area.For device analysis on product 2 this revealed, the body/shaft leakage was caused by a rupture on the body/shaft transition to balloon area.The inner surface presented evidence of elongations adjacent to the body/shaft transition to balloon rupture.The outer surface noted scratch marks adjacent to the body/shaft transition to balloon area.Based on the information provided it appears the body/shaft leakage was caused by the interaction of the balloon material with a sharp object.It is likely vessel characteristics, although unknown, may have contributed to the reported event as calcification is known to easily damage balloon material.Given the elongations noted upon device analysis the catheters were also manipulated forcibly through the vasculature and extreme care must be taken when handling the balloon catheters.According to the instructions for use, which are not intended to mitigate risk, ¿prior to angioplasty, the catheter should be examined to verify functionality and integrity, and ensure that its size and shape are suitable for the specific procedure for which it is to be used.Do not use if product damage is suspected or evident.To reduce the potential for vessel damage or the risk of dislodgement of particles it is very important that the inflated diameter of the balloon should approximate the diameter of the vessel just proximal and distal to the lesion.Preparation 1.Attach a 3-way stopcock to the inflation port, which is marked ¿balloon¿.2.Attach a partially filled syringe with heparinized saline to the stopcock, open the stopcock to the balloon and induce negative pressure.3.Hold the syringe and proximal end of the catheter above the distal end of the catheter, and hold the balloon vertically with the balloon tip pointing down.4.While maintaining negative pressure close the stopcock to the inflation port.Remove the syringe and purge the air.5.To ensure air contained in the balloon and inflation lumen is removed, apply negative pressure twice as instructed and repeat steps 2-4.6.Without twisting, slide the forming tube off the balloon.7.Prepare an angioplasty inflation system with a 50% solution of contrast medium in sterile saline or similar solution.8.Purge the air from the inflation device.9.Connect the inflation device to the 3-way stopcock that is connected to the catheter inflation port, open the stopcock to the catheter and slowly fill the inflation lumen and the balloon will slowly fill with diluted contrast medium.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 phr nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action will be taken at this time.

• Brand Name: SABER RX6MM10CM155
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tipperary 0000 ; EI 0000
• MDR Report Key: 9946650
• MDR Text Key: 193423590
• Report Number: 9616099-2020-03637
• 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: 05/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 51006010L
• Device Catalogue Number: 51006010L
• Device Lot Number: 82181109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2020
• Date Manufacturer Received: 04/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE (300CM VASSALLO FLOPPY, FILMECC)