MAUDE Adverse Event Report: CORDIS CORPORATION SLALOM PTA .018 HP 40 5X4; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number 4395040T

Device Problem Burst Container or Vessel (1074)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/26/2022

Event Type  malfunction  

Event Description

As reported, the balloon of a 5mm x 4mm high pressure (hp) 40 slalom thrill percutaneous transluminal angioplasty (pta) balloon catheter ruptured during an inflation to 6 atmospheres (atm).As a result, the 5mm x 4mm slalom thrill pta balloon catheter was replaced by a non-cordis balloon catheter to complete the procedure.There was no reported injury to the patient.This was during a procedure to treat a shunt lesion.Additional information was requested but was not provided.The device was discarded and will not be returned.

Manufacturer Narrative

Complaint conclusion: as reported, the balloon of a 5mm x 4mm high pressure (hp) 40 slalom thrill percutaneous transluminal angioplasty (pta) balloon catheter ruptured during an inflation to six atmospheres (atm).As a result, the 5mm x 4mm slalom thrill pta balloon catheter was replaced by a non-cordis balloon catheter to complete the procedure.There was no reported injury to the patient.This was during a procedure to treat a shunt lesion.Additional information was requested but was not provided.The device was not returned for analysis as it was discarded.A product history record (phr) review of lot 82223649 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst - at/below rbp¿ could not be confirmed as the device was not returned for analysis.The exact cause of the reported event could not be determined.The procedure performed was a shunt percutaneous transluminal angioplasty (pta) case.Arteriovenous shunts are often scarred and fibrous in nature and therefore often resistant to balloon expansion increasing the likelihood of damage to the balloon.However, without the return of the device for analysis it is difficult to draw a clinical conclusion between the device and the event reported.According to the instructions for use ¿if resistance is met during manipulation, determine the cause of the resistance before proceeding.Balloon pressure should not exceed the rated burst pressure.The rated burst pressure is based on the results of in-vitro testing.At least 99.9% of the balloons (with a 95% confidence), will not burst at or below their rated burst pressure.Use of a pressure monitoring device is recommended to prevent over pressurization.Use only the recommended balloon inflation medium.Never use air or any gaseous medium to inflate the balloon.¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action will be taken at this time.

• Brand Name: SLALOM PTA .018 HP 40 5X4
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATIO; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 14745120
• MDR Text Key: 300317434
• Report Number: 9616099-2022-05724
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032061657
• UDI-Public: (01)20705032061657(17)240531(10)82223649
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4395040T
• Device Lot Number: 82223649
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2022
• Date Device Manufactured: 06/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK BALLOON CATHETER.