MAUDE Adverse Event Report: CORDIS CASHEL SABER RX5MM30CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 51005030L

Device Problem Burst Container or Vessel (1074)

Patient Problem Thrombosis (2100)

Event Date 08/08/2017

Event Type  malfunction  

Manufacturer Narrative

Complaint conclusion: as reported, a saber rx balloon catheter (5 mm 30 cm 155) was inserted for a pre-dilatation.However, it could not cross the lesion.So another balloon catheter (smaller size) was delivered for pre dilatation and the saber rx was attempted to be delivered again.However, this time it ruptured at the distal end of the balloon.The balloon was removed intact (in one piece).Therefore, it was replaced with a new balloon catheter.The procedure finished successfully.There was no reported patient injury.The target lesion was the superficial femoral artery (sfa).The patient¿s vessel level of tortuosity and stenosis is unknown.The lesion was calcified.There was no difficulty removing the product from the hoop or removing the protective balloon cover.There was no difficulty removing 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 device prepped normally, maintain negative pressure).No additional information is available.The device was not returned for analysis.A device history record (dhr) review of lot 17655851 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿pta/ptca catheter failure to cross¿ and ¿balloon burst - at/below rbp¿ could not be confirmed as the device was not returned for analysis.The exact cause of the failure to cross and the burst could not be determined.Based on the limited information available for review, vessel characteristics (calcified) may have contributed to the reported event as calcification/resistant lesions may cause damage to a balloon, especially if there was difficulty crossing the lesion.Difficulty crossing 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.Crossing 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.

Event Description

As reported, a saber rx balloon catheter (5 mm 30 cm 155) was inserted for a pre-dilatation.However, it could not cross the lesion.So another balloon catheter (smaller size) was delivered for pre dilatation and the saber rx was attempted to be delivered again.However, this time it ruptured at the distal end of the balloon.The balloon was removed intact (in one piece).Therefore, it was replaced with a new balloon catheter.The procedure finished successfully.There was no reported patient injury.The product will not be returned for analysis.The target lesion was the superficial femoral artery (sfa).The patient¿s vessel level of tortuosity and stenosis is unknown.The lesion was calcified.There was no difficulty removing the product from the hoop or removing the protective balloon cover.There was no difficulty removing 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 device prepped normally, maintain negative pressure.No additional information is available.

• Brand Name: SABER RX5MM30CM155
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cashir rd; tipperarry ; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; tipperrary ; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6807141
• MDR Text Key: 83309270
• Report Number: 9616099-2017-01340
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: 51005030L
• Device Catalogue Number: 51005030L
• Device Lot Number: 17655851
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/08/2017
• Date Manufacturer Received: 08/08/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/06/2017
• 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