MAUDE Adverse Event Report: CORDIS CASHEL SABER RX4MM30CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number 51004030L

Device Problem Structural Problem (2506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2019

Event Type  malfunction  

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, a plain old balloon angioplasty (poba) was performed with a saber rx pta balloon catheter (4mm30cm155) ), the saber rx pta balloon was inflated within its nominal pressure. However, the balloon got lengthened from about 1. 5 to 2-centimeters (cm) from the proximal maker and it was inflated. There was no reported patient injury. Yet, the doctor wondered how long the acceptable length is. The lesion was the superficial femoral artery. Initially, this was a percutaneous transluminal angioplasty (pta) case. A contralateral approach was made with a non-cordis guiding catheter and a non-cordis guide wire crossed the lesion. The contrast to saline ration was 1:1: the device will be returned for analysis.

• Brand Name: SABER RX4MM30CM155
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co.; tipperary ; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, co.; tipperary ; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 8743846
• MDR Text Key: 150280119
• Report Number: 9616099-2019-03042
• 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: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/31/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 51004030L
• Device Lot Number: 82159348
• 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: 07/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial