MAUDE Adverse Event Report: CORDIS CASHEL SLALOM PTA .018 HP 40 3X4 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number 4393040T

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2019

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot (17728332) presented no issues during the manufacturing process that can be related to the reported event. Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, a slalom thrill pta balloon catheter (. 018 hp 40 3x4) was used without any problems at the procedure. However, after the procedure, it was confirmed that the tip was about to come off. There was no reported patient injury. This was shunt percutaneous transluminal angioplasty case. The device was stored and handled per the instructions for use (ifu). There was no damage noted to the inner package. The integrity of the sterile pouch was not compromised. There were no anomalies noted to the device when it was taken out of the packaging. The device was prepped according to instructions for use (ifu). There were no anomalies noted during or after the device was prepped. There were no kinks or other damages noted prior to inserting the product into the patient. There was no resistance advancing the device. There were no kink/bent noted after device was removed from patient. There was no unusual force used at any time during the procedure. There was no part of the device that fractured nor separated inside the patient body. There was no part of the device that migrated inside the patient¿s body. The device was removed intact (in one piece) from the patient. There was no patient injury. There is no procedural film/cd available for review. The device will be returned for analysis.

• Brand Name: SLALOM PTA .018 HP 40 3X4
• 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: 9115424
• MDR Text Key: 160044116
• Report Number: 9616099-2019-03222
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K003159
• 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: 10/17/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 4393040T
• Device Lot Number: 17728332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial