MAUDE Adverse Event Report: CORDIS CASHEL SABER 4MM15CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 48004015X

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2019

Event Type  malfunction  

Manufacturer Narrative

During a lower extremity artery surgery, the non-cordis guidewire cannot be withdrawn by using the 4mm x 15cm 150 saber balloon catheter.The device could not be withdrawn after expansion, so the guidewire and the balloon were withdrawn together.There was no patient injury reported.There was no resistance/friction between the devices.The target lesion was the superficial femoral artery (sfa).The lesion had severe calcification and the device was used for a chronic total occlusion.The product was stored, handled, inspected, and prepped according to the instructions for use (ifu).The device did prep normally.There was nothing unusual noted about the device prior to use.There was no difficulty removing the product from the hoop.There was no difficulty removing 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 into the patient.The balloon catheter did not kink while being used.Other products were successfully used with the device prior to the encountered resistance.The guidewire could pass through the device.There was a contrast to saline ratio of 1:1.There was no difficulty advancing the balloon catheter through the vessel.There was no difficulty crossing the lesion.The catheter was in an acute bend.A contralateral approach was used, and the degree was acute.There was no unusual force used at any time during the procedure.The balloon catheter was removed easily.The product was removed intact (in one piece) from the patient.The procedure was completed without patient injury.The product was returned for analysis.A non-sterile unit of saber 4mm x 15cm 150cm pta balloon catheter (bc) was received for analysis coiled inside a plastic bag, along with a guide wire.No original packaging was returned.Per visual analysis, the guide wire was stuck inside the catheter.The body/shaft is wrinkled inside the hub and at the strain relief.Furthermore, the outer body has a hole 5cm from the proximal marker bands.Dried saline solution residues were observed.The tip is bent from the distal marker band.Per dimensional analysis, after removal of guide wire received with catheter, dimensions were within specification.Functional analysis was not possible due to the condition of the device.Per sem analysis the hole was caused by a rupture on the guidewire lumen surface.The outer surface presented evidence of elongations and scratch marks near the rupture.The inner surface presented evidence of elongations and scratch marks near to the guidewire lumen rupture.This type of damage is commonly caused during the interaction of the guidewire lumen material with a sharp object or mechanical damage.It is very likely that the same factors that caused the observed elongations and scratch marks on the guidewire lumen outer and inner surface could probably led to the rupture condition found on the device.It seems the guidewire lumen material near the rupture was peeled off with a sharp object from the outside the lumen and scratched the lumen inner surface.No other anomalies were found during the sem analysis.A product history record (phr) review of lot 17689098 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿guidewire lumen resistance/friction - in-patient¿ and ¿body/shaft puncture/cut - in-patient¿ were confirmed through analysis of the returned device.The exact cause of the event could not be determined during analysis.Based on the information available for review, device interaction and procedural factors may have contributed to the event as evidenced by elongations and scratch marks near the site of rupture, and the guide wire being stuck in the balloon catheter when returned, and despite the saber bc being within specification when the dimensions were measured, as noted during analysis.Therefore, it is assumed that a mechanical damage due to a sharp object caused the condition on the balloon.Nonetheless, the cause of the device condition could not be conclusively determined during the analysis.According to the safety information of the instructions for use ¿if resistance is felt upon removal, then the balloon, guidewire and the sheath should be removed together as a unit, particularly if balloon rupture or leakage is known or suspected.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.Always verify integrity of the catheter after removal.¿ neither the phr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.

Event Description

As reported, during a lower extremity artery surgery, the non-cordis guidewire can not be withdrawn by using the 4mm x 15cm 150 saber balloon catheter.The device could not be withdrawn after expansion, so the guidewire and the balloon were withdrawn together.Per product evaluation of the received device, the outer body presents a hole 5 cm from the proximal marker bands.There was no patient injury reported.There was no resistance/friction between the devices.The target lesion was the superficial femoral artery (sfa).The lesion had severe calcification and the device was used for a chronic total occlusion.The product was stored, handled, inspected, and prepped according to the instructions for use (ifu).The device did prep normally.There was nothing unusual noted about the device prior to use.There was no difficulty removing the product from the hoop.There was no difficulty removing 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 into the patient.The balloon catheter did not kink while being used.Other products were successfully used with the device prior to the encountered resistance.The guidewire could pass through the device.The contrast media used was ge iodixanol and it was a contrast to saline ratio of 1:1.There was no difficulty advancing the balloon catheter through the vessel.There was no difficulty crossing the lesion.The catheter was in an acute bend.A contralateral approach was used, and the degree was acute.There was no unusual force used at any time during the procedure.The balloon catheter was removed easily.The product was removed intact (in one piece) from the patient.The procedure was completed without patient injury.

• Brand Name: SABER 4MM15CM 150
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 8932056
• MDR Text Key: 198345559
• Report Number: 9616099-2019-03164
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032069486
• UDI-Public: 20705032069486
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K971010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2020
• Device Model Number: 48004015X
• Device Catalogue Number: 48004015X
• Device Lot Number: 17689098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 62