MAUDE Adverse Event Report: CORDIS CASHEL SABER 8MM4CM 90; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number 48008004S

Device Problem Burst Container or Vessel (1074)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/03/2019

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 17625100 presented no issues during the manufacturing process that can be related to the reported event.This device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the 80 mm x 4 cm saber percutaneous transluminal angioplasty (pta) balloon catheter burst in the patient.Another saber pta catheter was used to complete the procedure.There was no reported patient injury.The device is expected to be returned for evaluation.The device was intended to be used in a fistula arm case.There was no difficulty removing the product from its packaging.There were no kinks or other damages noted prior to inserting the product the product into the patient.The device prepped normally.The contrast to saline ratio was 40/60.A non-cordis inflation device was used, which had previously been successfully used with other devices.The fistula had little calcification, no tortuosity and had a rate of 90% stenosis.There was no difficulty advancing the balloon catheter through the vessel, nor was there any difficulty crossing the lesion.The catheter was never in an acute bend.The plunger did not depress into the syringe/indeflator when trying to inflate.The maximum inflation pressure was 12atm.The product was removed intact from the patient.

Manufacturer Narrative

Complaint conclusion the 80mm x 4cm saber percutaneous transluminal angioplasty (pta) balloon catheter burst in the patient.Another saber pta catheter was used to complete the procedure.There was no reported patient injury.The device was intended to be used in a fistula arm case.The fistula had little calcification, no tortuosity and had a rate of 90% stenosis.The plunger did not depress into the syringe/indeflator when trying to inflate.The maximum inflation pressure was 12atm.There was no difficulty removing the product from its packaging.There were no kinks or other damages noted prior to inserting the product into the patient.The device prepped normally.The contrast to saline ratio was 40/60.A non-cordis inflation device was used, which had previously been successfully used with other devices.There was no difficulty advancing the balloon catheter through the vessel, nor was there any difficulty crossing the lesion.The catheter was never in an acute bend.The product was removed intact from the patient.One product was returned for analysis.A non-sterile saber 8mm x 4cm x 90 pta balloon catheter was received.Per visual analysis, the device was coiled inside a plastic bag.The unit was received inserted into a cordis 5f catheter sheath introducer.The balloon appears to have been previously inflated.Blood residues were observed inside the balloon and a burst was noted to the device.Sem analysis revealed the balloon burst was caused by a rupture on the balloon surface.The inner surface presented no anomalies adjacent to the balloon rupture.The outer surface presented evidence of scratch marks and tears adjacent to the balloon rupture.This type of damage is commonly caused during the interaction of the balloon material with a sharp object or mechanical damage.No other anomalies were observed during the sem analysis.A product history record (phr) review of lot 17625100 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst-at/below rbp¿ was confirmed through analysis of the returned device.However, the exact cause of the burst could not be determined.It is likely the outer surface of the balloon material encountered a sharp object or mechanical damage.As scratch marks adjacent to the rupture were noted upon analysis to the outer portion of the balloon.It appears the balloon material adjacent to the rupture was torn with a sharp object from the outside of the balloon.Based on the information available for review, vessel characteristics of calcification and 90% stenosis may have contributed to the rupture; as calcium is known to damage balloon material.According to the warnings in the safety information in the instructions for use ¿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.The balloon dimensions are printed on the product label.The compliance table incorporated with the product shows how balloon diameter increases as pressure increases.Do not exceed the rated burst pressure recommended on the label.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.Pressure in excess of the rated burst pressure can cause balloon rupture and potential inability to withdraw the catheter through the introducer sheath.Balloon rupture can cause vessel damage and the need for additional intervention.Use only the recommended balloon inflation medium (a 50/50 mixture by volume of contrast medium and normal saline).Never use air or any gaseous medium to inflate the balloon.¿ 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 or preventive action will be taken at this time.

• Brand Name: SABER 8MM4CM 90
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 9125413
• MDR Text Key: 160567877
• Report Number: 9616099-2019-03233
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032068908
• UDI-Public: 20705032068908
• Combination Product (y/n): N
• PMA/PMN Number: K971010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 48008004S
• Device Lot Number: 17625100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2019
• Initial Date Manufacturer Received: 09/03/2019
• Initial Date FDA Received: 09/26/2019
• Supplement Dates Manufacturer Received: 10/25/2019
• Supplement Dates FDA Received: 11/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SABER PTA (4800804S)