MAUDE Adverse Event Report: CORDIS CASHEL SLALOM PTA .018 HP 40 6X4 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 4396040T

Device Problem Burst Container or Vessel (1074)

Patient Problem Pain (1994)

Event Date 12/04/2019

Event Type  malfunction  

Manufacturer Narrative

This device was received for analysis but the engineering report is not yet available. However, it will be submitted within 30 days upon receipt. A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.

Event Description

As reported, the balloon of a. 018 6 x 4 40 slalom percutaneous transluminal angioplasty (pta) ruptured as the physician confirmed that blood builded up inside the balloon. The device was inflated at fourteen atmospheres (14 atms) for three minutes as its initial inflation. The balloon middle part was not inflated enough, so a guide wire (35) was placed next to the balloon to split the stenosis part. The complaint slalom thrill was inflated as second inflation. It was inflated at 14 atms for one and a half minutes. However, the patient complained of pain. The inflation was suspended. The device was removed from the patient. This was a shunt pta case. There was no reported patient injury. The physician requested a customer letter. The device is expected to be returned for evaluation.

• Brand Name: SLALOM PTA .018 HP 40 6X4
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tipperary 0000 ; EI 0000
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, tipperary 0000 ; EI 0000
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 9539641
• MDR Text Key: 199860047
• Report Number: 9616099-2020-03449
• 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

• Type of Report: Initial,Followup
• Report Date: 01/23/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/31/2019
• Device Model Number: 4396040T
• Device Catalogue Number: 4396040T
• Device Lot Number: 17636408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2019
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial