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

Model Number N/A

Device Problems Decrease in Pressure (1490); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/04/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6). This device is available for analysis but has not yet been received. Additional information is pending and will be submitted within 30 days upon receipt. Please note that this device is not sold in the us but it is similar to other cordis pta balloon catheters sold in the u. S. With the lit product code.

Event Description

A 7 mm 4 cm 155 saber rx percutaneous transluminal angioplasty (pta) balloon catheter ruptured at 10 atmospheres (atm) while being ¿used to implant a non-cordis stent. The balloon catheter was replaced with a new saber, 6 x 150 which could inflate. There was no patient injury and the device will be returned for analysis.

• Brand Name: SABER RX7MM4CM155
• Type of Device: PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 9134085
• MDR Text Key: 160567270
• Report Number: 9616099-2019-03238
• 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: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 51007004L
• Device Lot Number: 82168866
• 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: 11/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 09/30/2019 Patient Sequence Number: 1

Treatment

STENT (LIFESTENT, MEDICON)