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

Catalog Number 48002004X

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2015

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 percutaneous transluminal angioplasty (pta) ruptured during dilatation. Therefore the balloon was changed to another balloon (same size). The procedure was finished successfully. There was no reported patient injury. The product will not be returned for analysis. The target lesion was the left superficial femoral artery (cto). The rate of stenosis was unknown. A contralateral approach was made. The saber balloon catheter was used for back-up and a guidewire was approached to the lesion. The back-up was not enough and the handle ability of the guidewire got low quality. Therefore the balloon was inflated at place the balloon passed and the guiding catheter was delivered to the ballooning place. After that, the guidewire was crossed the lesion (cto) and the physician tried to inflated the balloon at the remaining occluded part. However it ruptured during dilatation. The procedure was for the left superficial femoral artery (cto). The access site is unknown. It is unknown what location was initially dilated with the saber. 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. 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. The maximum inflation pressure is unknown. It is 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 percutaneous transluminal angioplasty (pta) balloon catheter ruptured during dilatation. Therefore the balloon was changed to another balloon (same size). The procedure was finished successfully. There was no reported patient injury. The target lesion was the left superficial femoral artery. It was a chronic total occlusion (cto). The rate of stenosis is unknown. A contralateral approach was made. The saber balloon catheter was used for back-up and a guidewire was approached to the lesion. The back-up was not enough and the handling ability of the guidewire was low quality. Therefore the balloon was inflated in place when the balloon passed and the guiding catheter was delivered to the ballooning place. After that, the guidewire crossed the lesion (cto) and the physician tried to inflate the balloon at the remaining occluded part. However it ruptured during dilatation. The procedure was for the left superficial femoral artery. The access site is unknown. It is unknown what location was initially dilated with the saber. 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. 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. The maximum inflation pressure is unknown. It is 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 was not returned for analysis. A device history record (dhr) review of lot 17096517 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event. The reported ¿balloon burst (peripheral)¿ could not be confirmed as the device was not returned for analysis. The exact cause could not be determined. Vessel characteristics of a chronic total occlusion 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: SABER 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: 5293318
• MDR Text Key: 33426178
• Report Number: 9616099-2015-00643
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (Y/N): N
• Reporter Country Code: JA
• PMA/PMN Number: K971010
• 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

0 PatientS WERE Involved in the Event:

• Date FDA Received: 12/14/2015
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 08/31/2017
• Device Catalogue Number: 48002004X
• Device LOT Number: 17096517
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/13/2015
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 09/18/2014
• Is The Device Single Use?: Yes

Is this a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial