MAUDE Adverse Event Report: CORDIS CORPORATION SABERX PTA DILATATION CATHETER; PTA CATHETERS (LIT)

Catalog Number 51005004L

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/24/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(6).This device is not available for testing and evaluation.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

During an unspecified interventional procedure, a saber x ruptured at 6 atmospheres (atm) during its second dilatation.It was changed to another balloon to complete the procedure.The procedure was finished successfully.There was no reported patient injury.The product will not be returned for analysis.The target lesion was the external iliac artery.The rate of stenosis was unknown.A contralateral approach was made for heavily calcified.A saber balloon was delivered to the lesion.However, it ruptured at 6atm during its second-dilation and the leakage of media was observed.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.The brand of contrast and the contrast to saline ratio are unknown.The brand of inflation device was used is also unknown.It is unknown if the same indeflator was used successfully with other devices.It is unknown if there was any resistance/friction while inserting the balloon through the rotating hemostatic valve or while inserting the balloon through the guide catheter.It is unknown if there was any difficulty advancing the balloon catheter through the vessel and if there was any difficulty crossing the lesion.It is also unknown if the catheter was ever in an acute bend.It is unknown if the balloon inflated normally or if leakage was noted from the balloon, shaft, hub, or from an unknown segment.It is also unknown if the balloon catheter kinked while being used.It is unknown if the balloon catheter removed easily from the vessel and from the other devices.

Manufacturer Narrative

During an unspecified interventional procedure, a saber x ruptured at 6 atm (six atmospheres) during its second dilatation.It was changed to another balloon to complete the procedure.The procedure was finished successfully.There was no reported patient injury.The target lesion was the external iliac artery.The rate of stenosis was unknown.A contralateral approach was made for the vessel was heavily calcified.A saber balloon was delivered to the lesion.However it ruptured at 6 atm during its second-dilation and the leakage of media was observed.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.The brand of contrast and the contrast to saline ratio are unknown.The brand of inflation device was used is also unknown.It is unknown if the same indeflator was used successfully with other devices.It is unknown if there was any resistance/friction while inserting the balloon through the rotating hemostatic valve or while inserting the balloon through the guide catheter.It is unknown if there was any difficulty advancing the balloon catheter through the vessel and if there was any difficulty crossing the lesion.It is also unknown if the catheter was ever in an acute bend.It is unknown if the balloon inflated normally or if leakage was noted from the balloon, shaft, hub, or from an unknown segment.It is also unknown if the balloon catheter kinked while being used.It is unknown if the balloon catheter removed easily from the vessel and from the other devices.The product will not be returned for analysis.A device history record (dhr) review of lot 17279964 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.Vessel characteristics of heavy calcification may have contributed to the reported event.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.

• Brand Name: SABERX PTA DILATATION CATHETER
• Type of Device: PTA CATHETERS (LIT)
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL
• Manufacturer Contact: cecil navajas ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 7863133880
• MDR Report Key: 5311906
• MDR Text Key: 33935105
• Report Number: 9616099-2015-00666
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/25/2015

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: 05/31/2018
• Device Catalogue Number: 51005004L
• Device Lot Number: 17279964
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2015
• Initial Date FDA Received: 12/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1