MAUDE Adverse Event Report: CORDIS CASHEL SABER 3MM2CM 90; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	48003002S
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).The 3mm x 2cm x 90cm saber percutaneous transluminal angioplasty (pta) balloon dilatation catheter inflated in its initial inflation without any issues; however, it ruptured at its second inflation.The maximum inflation pressure was eight atmospheres when the balloon burst.There was no reported patient injury.The lesions were at below-knee (bk) and the anterior tibial artery with chronic total occlusion (cto).The lesion and the superficial femoral artery had severe calcification.There was no vessel tortuosity but did have 100% stenosis.An ipsilateral approach was made and was delivered to the lesion without any issues.Therefore, it was replaced with a new non-cordis balloon catheter and the procedure was completed.There was no anomaly noted to the product prior to use.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 prepped normally (i.E.Maintain 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 through the guide catheter.There was no difficulty advancing the balloon catheter through the vessel.The catheter was never in an acute bend.The product was removed easily and intact (in one piece) from the patient.Other additional procedural details were requested but were unknown.The product was not returned for analysis.A product history record (phr) review of lot 17651372 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 chronic total occlusion with 100% stenosis may have contributed to the reported event.A chronically occluded vessel makes crossing into the lesion very difficult; it is likely damage to balloon material occurred in the attempt to cross.However, without return of the product for analysis or films of the event it is difficult to draw a clinical conclusion between the device and the reported event.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 3mm 2cm 90cm saber percutaneous transluminal angioplasty (pta) balloon dilatation catheter could inflate in its initial inflation without any issues; however, it ruptured at its second inflation.The maximum inflation pressure was 8 atmospheres.The balloon burst at 8 atmospheres.Therefore, it was replaced with a new non-cordis balloon catheter and the procedure was completed.There was no reported patient injury.The device was discarded in the hospital.The lesions were at below-knee (bk) and the anterior tibial artery with chronic total occlusion (cto).An ipsilateral approach was made.There was no anomaly noted to the product prior to use.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 or other damages noted prior to inserting the product the product into the patient.The device prepped normally (i.E.Maintain negative pressure).The device could be delivered to the lesion without any issues.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.The lesion and the superficial femoral artery had severe calcification.There was no vessel tortuosity.There was 100% stenosis.There was no difficulty advancing the balloon catheter through the vessel.The catheter was never in an acute bend.The product was easily removed from the patient.The product was removed intact (in one piece) from the patient.Other additional procedural details were requested but were unknown.

• Brand Name: SABER 3MM2CM 90
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tipperary 0000 ; EI 0000
• MDR Report Key: 9842743
• Report Number: 9616099-2020-03567
• Device Sequence Number: 765041
• Product Code: LIT
• UDI-Device Identifier: 20705032068502
• UDI-Public: 20705032068502
• 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): 03/17/2020

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: 02/06/2023
• Device Model Number: 48003002S
• Device Catalogue Number: 48003002S
• Device Lot Number: 17651372
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 03/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1