MAUDE Adverse Event Report: CORDIS DE MEXICO SABER RX2MM4CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 51002004L

Device Problems Balloon (419); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2019

Event Type  Malfunction  

Manufacturer Narrative

Telephone number is: (b)(6). This device is available for analysis but has not yet been received. 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. Please note that the saber device in this report is not sold in the u. S, but it is similar to other cordis pta balloon catheters with the lit product code that are sold in the u. S.

Event Description

During a pre - plain old balloon angioplasty (poba) procedure, the balloon of the 2mm x 4cm x 155cm saber rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter crossed the lesion however it ruptured within its nominal pressure. Therefore, the device was removed from the patient's body and the procedure was completed with a non-cordis balloon catheter. There was no reported patient injury. The target lesion was the superficial femoral artery (sfa) and had calcification. The device was prepped without any issue. The device is expected to be returned for evaluation.

• Brand Name: SABER RX2MM4CM155
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer (Section G): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 9535447
• MDR Text Key: 200249816
• Report Number: 9616099-2019-03445
• 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,Followup
• Report Date: 02/11/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 12/31/2019
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 03/31/2020
• Device MODEL Number: 51002004L
• Device Catalogue Number: 51002004L
• Device LOT Number: 17661083
• Was Device Available For Evaluation?: Yes
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/06/2020
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 04/04/2017
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial