MAUDE Adverse Event Report: CORDIS CORPORATION SABER RX4MM15CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 51004015L

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2016

Event Type  malfunction  

Manufacturer Narrative

A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.  additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the 155 cm.Saber rx 4 mm.X 15 cm.Pta balloon catheter was delivered to the lesion, inflated, and then it ruptured.There was no reported patient injury.It was unknown how the procedure was completed, but it was completed successfully.The target lesion, vessel level of tortuousness, calcification, and rate of stenosis was unknown.The product was clinically used, and it will not be returned for analysis.Additional information received: there was no other product issue noted either at the account or after the procedure.There were no anomalies noted during the prep of the device.There was no damage noted to the box, pouch, hoop or balloon sleeve.There was no difficulty removing the balloon sleeve.There were no kinks noted on the device prior to use.The device did not separate or break into two or more pieces at any time during the procedure.Additional investigational questions were answered as unknown.

Manufacturer Narrative

Complaint conclusion-a 155 cm.Saber rx 4 mm.X 15 cm.Pta balloon catheter was delivered to the lesion, inflated, and then it ruptured.There was no reported patient injury.It was unknown how the procedure was completed, but it was completed successfully.The target lesion, vessel level of tortuousness, calcification, and rate of stenosis was unknown.The product was clinically used, and it will not be returned for analysis.Additional information received: there was no other product issue noted either at the account or after the procedure.There were no anomalies noted during the prep of the device.There was no damage noted to the box, pouch, hoop or balloon sleeve.There was no difficulty removing the balloon sleeve.There were no kinks noted on the device prior to use.The device did not separate or break into two or more pieces at any time during the procedure.Additional investigational questions were answered as unknown.The device was not returned for analysis.A device history record (dhr) review of lot 17415474 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics were not provided.According to the instructions for use, ¿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.¿ 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 RX4MM15CM155
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer (Section G): CORDIS DE MEXICO; circuito int nte 1820; juarez 32580 ; MX 32580
• Manufacturer Contact: cecil navajas ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6216024
• MDR Text Key: 63660221
• Report Number: 9616099-2016-00821
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: 51004015L
• Device Catalogue Number: 51004015L
• Device Lot Number: 17415474
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/11/2017
• Date Manufacturer Received: 12/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1