MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 4MM22CM 135; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 4400422X

Device Problem Crack (1135)

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

Event Date 02/14/2022

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 82222609 presented no issues during the manufacturing process that can be related to the reported event.This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, a 4mm x 22cm 135cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter was found to be cracked during a balloon inflation to 10 atmospheres (atm).As a result, the balloon was immediately deflated and the device was replaced with another 4mm x 22cm cordis balloon catheter to complete the procedure.There was no reported injury to the patient.This was during a procedure to treat a 70% stenosis in the superficial femoral artery (sfa) in which the powerflex pro pta balloon catheter was used for pre-dilation of the lesion.There was no calcification or tortuosity to the target vessel and the lesion was not a chronic total occlusion (cto).There was no difficulty removing the product from the hoop, protective balloon cover, the stylet, or any of the sterile packaging components.The device maintained negative pressure during preparation and an unknown inflation device was prepped with bayer contrast at a 1:1 contrast to saline ratio.The same, unknown inflation device was used successfully with other devices during the procedure.There was no resistance or friction experienced as the balloon entered the patient.There was no difficulty advancing the balloon catheter through the vessel, no difficulty crossing the lesion, and the device was never in an acute bend.The crack was visualized by evidence of an outflow of contrast agent form the device; however, the device did not separate as a result of the damage and was removed in one piece.Additionally, there was a noticeable drop in atmospheres upon the crack to the device.The device will be returned for evaluation.

Manufacturer Narrative

Complaint conclusion: as reported, a 4mm x 22cm 135cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter was found to be cracked during a balloon inflation to 10 atmospheres (atm).As a result, the balloon was immediately deflated, and the device was replaced with another 4mm x 22cm cordis balloon catheter to complete the procedure.There was no reported injury to the patient.This was during a procedure to treat a 70% stenosis in the superficial femoral artery (sfa) in which the powerflex pro pta balloon catheter was used for pre-dilation of the lesion.There was no calcification or tortuosity to the target vessel and the lesion was not a chronic total occlusion (cto).There was no difficulty removing the product from the hoop, protective balloon cover, the stylet, or any of the sterile packaging components.The device maintained negative pressure during preparation and an unknown inflation device was prepped with bayer contrast at a 1:1 contrast to saline ratio.The same, unknown inflation device was used successfully with other devices during the procedure.There was no resistance or friction experienced as the balloon entered the patient.There was no difficulty advancing the balloon catheter through the vessel, no difficulty crossing the lesion, and the device was never in an acute bend.The crack was visualized by evidence of an outflow of contrast agent form the device; however, the device did not separate because of the damage and was removed in one piece.Additionally, there was a noticeable drop in atmospheres upon the crack to the device.The device was returned for analysis.A non-sterile powerflex pro 4mm x 22cm 135 percutaneous transluminal angioplasty (pta) balloon catheter was received for analysis coiled inside a plastic bag.Per visual analysis, neither a crack nor any anomalies were found.Per functional testing, a lab sample inflator/deflator device partially filled with water was attached to the guidewire lumen as well as on the inflation lumen of the unit and positive pressure was applied.The flushing and inflation test were successfully performed.Neither a leak nor any other anomalies were observed.A product history record (phr) review of lot 82222609 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿pta/ptca system cracked - in-patient¿ 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.The returned product passed functional testing and no anomalies were noted.The balloon was inflated without any issues and the guidewire lumen successfully flushed.Therefore, based on the information available for review, it is difficult to draw a clinical conclusion between the device and the event reported as no anomalies were noted upon device analysis.According to the safety information in the instructions for use ¿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.Flush the ¿thru¿ lumen with sterile heparinized saline or a similar isotonic solution.Place the prepared catheter over a prepositioned guidewire and advance the tip to the introduction site.If resistance is met during manipulation, determine the cause of the resistance before proceeding.Consider the use of systemic heparinization.Flush all devices entering the vascular system with sterile heparinized saline or similar isotonic solution.If strong resistance is met during advancement or withdrawal of the catheter, discontinue movement and determine the cause of resistance before proceeding.If the cause of resistance cannot be determined, withdraw the entire system.¿ 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 4MM22CM 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: 13996566
• MDR Text Key: 291238801
• Report Number: 9616099-2022-05510
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032059272
• UDI-Public: (01)20705032059272(17)240430(10)82222609
• 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,Followup
• Report Date: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4400422X
• Device Catalogue Number: 4400422X
• Device Lot Number: 82222609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2021
• 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: 4MM X 22CM CORDIS BALLOON CATHETER; BAYER CONTRAST; UNKNOWN INFLATION DEVICE