MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 4MM10CM 135; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 4400410X

Device Problem Burst Container or Vessel (1074)

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

Event Date 02/14/2022

Event Type  malfunction  

Event Description

As reported, the balloon of a 4mm x 10cm 135cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter ruptured during preparation of the device and was unable to be inflated.As a result, a 6mm x 80mm cordis balloon catheter was used to complete the procedure and there was no reported injury to the patient.This was during a procedure in which the powerflex pro pta balloon catheter was to be used on a calcified and tortuous lesion.There was no difficulty removing the device from the hoop, removing the protective balloon cover, the stylet, or any of the sterile packaging components.Additionally, the balloon remained in one piece after the rupture occurred.Further information regarding which cordis balloon completed the procedure, contrast media used, contrast to saline ratio, inflation device used, target lesion, and percentage of stenosis/presence of a chronic total occlusion (cto) was requested but not provided, and the device will be returned for evaluation.

Manufacturer Narrative

As reported, the balloon of a 4mm x 10cm 135cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter ruptured during preparation of the device and was unable to be inflated.As a result, a 6mm x 80mm cordis balloon catheter was used to complete the procedure and there was no reported injury to the patient.This was during a procedure in which the powerflex pro pta balloon catheter was to be used on a calcified and tortuous lesion.There was no difficulty removing the device from the hoop, removing the protective balloon cover, the stylet, or any of the sterile packaging components.Additionally, the balloon remained in one piece after the rupture occurred.Further information regarding which cordis balloon completed the procedure, contrast media used, contrast to saline ratio, inflation device used, target lesion, and percentage of stenosis/presence of a chronic total occlusion (cto) was requested but not provided.The product was returned for analysis.A non-sterile powerflex pro 4mm x 10cm 135 percutaneous transluminal angioplasty (pta) was received for analysis inside a plastic bag.Per visual analysis, no anomalies were observed by the naked eye.Functional test was successfully performed on the unit.A lab sample inflator/ deflator device partially filled with water was attached to the inflation lumen of the unit and positive pressure was applied.The balloon was inflated as expected.Neither balloon burst nor any anomaly was observed.A product history record (phr) review of lot 82233910 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst¿ was not confirmed through analysis of the returned device.The exact cause of the reported event could not be determined.It is likely procedural factors and handling of the device, contributed to the event reported by the customer.Per functional analysis, the balloon was inflated, and no burst/leaks were noted.The device inflated without any issues to the balloon.Therefore, based on the information available for review, it is difficult to draw a clinical conclusion between the device and the event reported by the customer as no anomalies were noted on the device.According to the safety information in 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.Prior to angioplasty, the catheter should be examined to verify functionality and ensure that its size and shape are suitable for the specific procedure for which it is to be used.¿ 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: POWERFLEXPRO 4MM10CM 135
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 14043824
• MDR Text Key: 292842179
• Report Number: 9616099-2022-05528
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032059210
• UDI-Public: (01)20705032059210(17)240831(10)82233910
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K112797
• 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: 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2024
• Device Model Number: 4400410X
• Device Catalogue Number: 4400410X
• Device Lot Number: 82233910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2022
• Initial Date FDA Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2021
• 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: 6MM X 80MM CORDIS BALLOON CATHETER
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 57 KG