MAUDE Adverse Event Report: CORDIS CASHEL SABER 2MM2CM 90; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 48002002S

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2019

Event Type  malfunction  

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the 2mm x 2cm x 90cm saber percutaneous transluminal angioplasty (pta) balloon catheter ruptured at its nominal pressure during the second inflation.Therefore, it was removed easily intact in one piece from the patient as the guidewire remained.It was replaced with a new cordis balloon catheter and the procedure was completed.There was no reported patient injury.The device was intended for a below the knee procedure with an ipsilateral approach.The exact target lesion was the anterior tibial artery (ata).The 90% occluded target lesion had moderate calcification and little vessel tortuosity.There was calcification in the superficial femoral artery (sfa) up to the anterior tibial artery (ata).There was no difficulty removing the product from the hoop and 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 was prep normally and maintained negative pressure.The same indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve and the guide catheter.The catheter was not ever in an acute bend.The balloon maintained pressure during initial inflation, the maximum inflation was within its nominal pressure.The balloon catheter was not kinked while being used.Other additional procedural details were requested but are unknown.The device will not be returned for analysis since it was discarded in the hospital.

Manufacturer Narrative

The 2mm x 2cm x 90cm saber percutaneous transluminal angioplasty (pta) balloon catheter ruptured at its nominal pressure during the second inflation.There was no reported patient injury.The device was intended for a below the knee procedure with an ipsilateral approach.The exact target lesion was the anterior tibial artery (ata).The 90% occluded target lesion had moderate calcification and little vessel tortuosity.There was calcification in the superficial femoral artery (sfa) up to the anterior tibial artery (ata).It was removed easily and intact (in one piece) from the patient as the guidewire remained.It was replaced with a new cordis balloon catheter and the procedure was completed.There was no difficulty 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 into the patient.The device was prepped normally and maintained negative pressure.The same indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or the guide catheter.The catheter was not ever in an acute bend.The balloon maintained pressure during initial inflation, the maximum inflation was within its nominal pressure.The balloon catheter was not kinked while being used.Other additional procedural details were requested but are unknown.The product was not returned for analysis as it was discarded in the hospital.A product history record (phr) review of lot 17718392 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¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics of moderate calcification with a 90% occlusion likely contributed to the reported event.Calcification is known to damage balloon material; it is likely this occurred when attempting to cross the calcified lesion.However, without the return of the device for analysis, it is difficult to draw a clinical conclusion between the device and the event reported.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 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 2MM2CM 90
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 9582710
• MDR Text Key: 195043093
• Report Number: 9616099-2020-03474
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032069769
• UDI-Public: 20705032069769
• Combination Product (y/n): N
• PMA/PMN Number: K971010
• 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: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: 48002002S
• Device Catalogue Number: 48002002S
• Device Lot Number: 17718392
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1