MAUDE Adverse Event Report: CORDIS CASHEL SABER RX4MM2CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 51004002L

Device Problems Burst Container or Vessel (1074); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2018

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for analysis.Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

During use, it was reported that the saber balloon catheter had difficulty crossing the lesion and the balloon ruptured.There was no reported patient injury.Therefore the balloon was replaced with a new non cordis balloon catheter and the procedure was completed successfully.An ipsilateral antegrade approach was made.A guidewire crossed the lesion and a saber balloon was prepared as per the instruction for use (ifu) for pre dilatation.The saber balloon was inserted into the sheath introducer, but the balloon was difficult to deliver it to the lesion.Then the balloon was inflated in the calcified lesion and ruptured.The target lesion was the superficial femoral artery.The patient¿s vessel level of tortuousness was unknown.The lesion was calcified.The rate of stenosis was unknown.The product was clinically used and will not be returned for analysis.

Manufacturer Narrative

During use, it was reported that the 4x20mm 155cm saber balloon catheter (bc) had difficulty crossing the lesion and the balloon ruptured.Therefore the balloon was replaced with a new non cordis balloon catheter and the procedure was completed successfully.There was no reported patient injury.An ipsilateral antegrade approach was made.A guidewire crossed the lesion and a saber balloon was prepared as per the instruction for use (ifu) for pre-dilatation.The saber balloon was inserted into the sheath introducer, but the balloon was difficult to deliver it to the lesion.Then the balloon was inflated in the calcified lesion and ruptured.The target lesion was the superficial femoral artery.The patient¿s vessel level of tortuousness was unknown.The lesion was calcified.The rate of stenosis was unknown.The device was not returned for analysis.A device history record (dhr) review of lot 17274307 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿pta/ptca system tracking difficulty¿ and ¿balloon burst¿ could not be confirmed as the device was not returned for analysis.The exact cause of the tracking difficulty and burst could not be determined.Based on the limited information available for review, vessel characteristics (calcified) may have contributed to the reported event as calcified/resistant lesions may cause damage to a balloon and difficulty tracking through the lesion.Difficulty tracking a product through an anatomical structure is a known procedural occurrence.This type of difficulty occurring during the clinical use of the device is usually addressed by modification in technique or substitution with another device.Tracking difficulty is most commonly related to the patient¿s anatomy, vessel characteristics, operator¿s technique and appropriate device selection.According to the instructions for use, which is not intended as a mitigation, ¿the rated burst pressure is based on the results of in vitro testing.At least 99.9% of the balloons (with a 95% confidence) will not burst at or below their rated burst pressure.Use of a pressure monitoring device is recommended to prevent over-pressurization.Do not exceed the rated burst pressure recommended on the label.Prior to angioplasty, the catheter should be examined to verify functionality and ensure that its size and shape are suitable for the specific procedure for which it is to be used.¿ neither the dhr nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective/preventive action will be taken at this time.

Manufacturer Narrative

Additional information was received and event was updated, see first paragraph below.During use the 4x20mm 155cm saber balloon catheter (bc) had difficulty crossing the lesion and the balloon ruptured.Therefore the balloon was replaced with a new non cordis balloon catheter and the procedure was completed successfully.There was no reported patient injury.The patient¿s vessel level of tortuousness was moderate.The lesion was severely calcified.The rate of stenosis was 90%.An ipsilateral antegrade approach was made.A guidewire crossed the lesion and a saber balloon was prepared as per the instruction for use (ifu) for pre-dilatation.The saber balloon was inserted into the sheath introducer, but the balloon was difficult to deliver it to the lesion.Then the balloon was inflated in the calcified lesion and ruptured.The target lesion was the superficial femoral artery.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.A competitor's inflation device was used.The inflation device was successfully used with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or the guide catheter.The catheter has never been in an acute bend.The product was removed intact (in one piece) from the patient.The device was not returned for analysis.A device history record (dhr) review of lot: 17274307 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿pta/ptca system tracking difficulty¿ and ¿balloon burst¿ could not be confirmed as the device was not returned for analysis.The exact cause of the tracking difficulty and burst could not be determined.Based on the limited information available for review, vessel characteristics (moderate tortuosity, severe calcification and a rate of stenosis of 90%) may have contributed to the reported event as calcified/resistant lesions may cause damage to a balloon and difficulty tracking through the lesion.Difficulty tracking a product through an anatomical structure is a known procedural occurrence.This type of difficulty occurring during the clinical use of the device is usually addressed by modification in technique or substitution with another device.Tracking difficulty is most commonly related to the patient¿s anatomy, vessel characteristics, operator¿s technique and appropriate device selection.According to the instructions for use, which is not intended as a mitigation, ¿the rated burst pressure is based on the results of in vitro testing.At least 99.9% of the balloons (with a 95% confidence) will not burst at or below their rated burst pressure.Use of a pressure monitoring device is recommended to prevent over-pressurization.Do not exceed the rated burst pressure recommended on the label.Prior to angioplasty, the catheter should be examined to verify functionality and ensure that its size and shape are suitable for the specific procedure for which it is to be used.¿ neither the dhr nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective/preventive action will be taken at this time.

• Brand Name: SABER RX4MM2CM155
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tipperary ; EI
• MDR Report Key: 7266390
• MDR Text Key: 100058901
• Report Number: 9616099-2018-01846
• 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: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: 51004002L
• Device Catalogue Number: 51004002L
• Device Lot Number: 17274307
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/16/2018
• Date Manufacturer Received: 03/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BALLOON CATHETER - ULTRAVERSE, C. R. BARD