MAUDE Adverse Event Report: CORDIS CASHEL SABER RX7MM4CM155 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER

Model Number N/A

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/24/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6). Concomitant medical products: guiding catheter (destination, terumoguidewire (cruise, asahi intecc). (b)(6). Please note that the device in this report is not sold in the us, however, it is similar to other cordis pta balloon catheters with the lit product code. The device was returned but the engineering report is pending. Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

During use of a 7mm4cm155 saber rx percutaneous transluminal angioplasty (pta) balloon catheter, there was an abnormality felt with the marker which seemed to be far away and out of position. The doctor decided that it could not be used safely, and it will be returned for analysis. The balloon had been delivered and inflated as usual. The 75% occluded target lesion was the left external iliac artery with moderate vessel tortuosity. The access site was the inguinal region. The procedure being performed was a stent that was implanted in the left external iliac artery. The contrast media used was opaque injection, fuji pharma at a 1:1 contrast to saline ratio. An everest indeflator by medtronic was used in the procedure. The same indeflator was used successfully with other devices. There was no resistance/friction while inserting the balloon through the rotating hemostatic valve and no resistance/friction while inserting the balloon through the guide catheter. There was no difficulty advancing the balloon catheter through the vessel and no difficulty crossing the lesion. The catheter was never in an acute bend. The event occurred at the lesion. The balloon inflated normally was there was no difficulty removing it.

• Brand Name: SABER RX7MM4CM155
• Type of Device: PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER
• Manufacturer (Section D): CORDIS CASHEL; cahir road; co, tipperaru; cashel ; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; co. tipperary; cashel ; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 8708527
• MDR Text Key: 197610437
• Report Number: 9616099-2019-03025
• 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: 07/31/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 51007004L
• Device Lot Number: 82160722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial