MAUDE Adverse Event Report: CORDIS CASHEL MAXI LD 7F 14X4 80CM; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4171440S
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the 14x40mm maxi ld balloon catheter ruptured at four atmospheres (4 atm) on calcium.The product was removed intact (in one piece) from the patient and the procedure was completed using a non cordis balloon catheter.There was no patient injury.The target lesion is the superficial femoral artery (sfa) which was moderately calcified with 60% stenosis.There was no vessel tortuosity.The device prepped according to the instruction for use (ifu) with no defects during prep.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.The contrast to saline ratio was 50/50.The same indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve, the guide catheter, or the vessel.There difficulty crossing the lesion.The catheter has never in an acute bend.  the device was not returned for analysis.A device history record (dhr) review of lot 17598464 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 (peripheral)¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Based on the information available for review, vessel characteristics (moderate calcification) may have contributed to the reported event.According to the instructions for use, ¿the rated burst pressure is printed on the package label.In vitro testing has shown that with 95% confidence, 99.9% of the balloons will not burst at or below the rated pressure.Balloons should not be inflated in excess of the rated burst pressure.¿ 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.
Event or Problem Description
It was reported that the 14x40mm maxi ld balloon catheter ruptured at four atmospheres (4 atm) on calcium.The product was removed intact (in one piece) from the patient and the procedure was completed using a non cordis balloon catheter.There was no patient injury.The target lesion is the superficial femoral artery (sfa) which was moderately calcified with 60% stenosis.There was no vessel tortuosity.The device prepped according to the instruction for use (ifu) with no defects during prep.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.The contrast to saline ratio was 50/50.The same indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve, the guide catheter, or the vessel.There difficulty crossing the lesion.The catheter has never in an acute bend.

• Brand Name: MAXI LD 7F 14X4 80CM
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tp ; EI
• MDR Report Key: 6560065
• Report Number: 9616099-2017-01085
• Device Sequence Number: 16318658
• Product Code: LIT
• UDI-Device Identifier: 20705032002438
• UDI-Public: 20705032002438
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/11/2017

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: 03/31/2018
• Device Model Number: 4171440S
• Device Catalogue Number: 4171440S
• Device Lot Number: 17598464
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/13/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2017
• Initial Report FDA Received Date: 05/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1