MAUDE Adverse Event Report: CORDIS CASHEL SABER 7MM4CM 90; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	48007004S
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products and therapy dates (exclude treatment of event): unk sv wire, unk balloon catheter (non cordis) and reporter phone number: (b)(6).The balloon of a 7mm x 4cm x 90 saber percutaneous transluminal angioplasty (pta) dilatation catheter was inflated; however, it ruptured at approximately six atmospheres (atm) during its initial inflation.There was no reported patient injury.This was postero-anterior (pa) inflation case in pediatrics.There was no vessel tortuosity and the lesion was described as having 99% stenosis.The device was not used for a chronic total occlusion (total occlusion >3 months).A non-cordis wire was crossed the lesion.The saber was removed from the patient¿s body and the procedure was completed by replacing it with a new non-cordis balloon catheter.The device was stored and handled per the instructions for use (ifu).The device was prepped normally by (maintain negative pressure) according to the ifu.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.A non-cordis indeflator/syringe was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or through the guide catheter.There was no difficulty advancing the balloon catheter through the vessel or crossing the lesion.The product was removed intact (in one piece) from the patient.The product was not returned for analysis as it was discarded.A product history record (phr) review of lot 17692833 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 99% stenosis may have contributed to the reported event, as a heavily stenosed lesion may damage balloon material when attempting to cross the lesion.However, without the return of the device for analysis it is difficult to draw a clinical conclusion between the device and 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.
Event or Problem Description
As reported, the balloon of a 7mm x 4cm x 90 saber percutaneous transluminal angioplasty (pta) dilatation catheter was inflated however, it ruptured at approximately 6 atmospheres (atm) in its initial inflation.Therefore, it was removed from the patient¿s body and the procedure was completed by replacing it with a new non-cordis balloon catheter.There was no reported patient injury.This was postero-anterior (pa) inflation case in pediatrics.A sv wire was crossed the lesion.The device was stored and handled per the instructions for use (ifu).The device was prepped according to the ifu.The device was prepped normally by maintain negative pressure.There was no difficulty removing the product from the hoop.There was no difficulty removing the protective balloon cover.There was no difficulty removing the stylet or any of the sterile packaging components.There were no kinks nor other damages noted prior to inserting the product into the patient.The indeflator/syringe used was an everest medtronic.The same indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve.There was no resistance/friction while inserting the balloon through the guide catheter.There was no vessel tortuosity.The lesion has 99% stenosis.The device was not used for a chronic total occlusion (total occlusion >3 months).There was no difficulty advancing the balloon catheter through the vessel.There was no difficulty crossing the lesion.The product was removed intact (in one piece) from the patient.The device will not be returned as it was discarded in the hospital.

• Brand Name: SABER 7MM4CM 90
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tipperary 0000 ; EI 0000
• MDR Report Key: 9783123
• Report Number: 9616099-2020-03546
• Device Sequence Number: 11390928
• Product Code: LIT
• UDI-Device Identifier: 20705032068847
• UDI-Public: 20705032068847
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K971010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/03/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: 48007004S
• Device Catalogue Number: 48007004S
• Device Lot Number: 17692833
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 03/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1