MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEX EXTREME 8X4 80CM; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4158040S
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the balloon of an 8mm x 4cm 80cm powerflex extreme percutaneous transluminal angioplasty (pta) balloon catheter ruptured during its first intrastent inflation.As a result, a 9mm x 40mm non-cordis balloon catheter was used in place of the 8mm x 4cm 80cm powerflex extreme pta without issue to complete the procedure.There was no reported injury to the patient.This was during a procedure to treat in-stent restenosis of a previously placed stent at the venous anastomosis.The lesion had mild calcification, an 80% stenosis, and was non a chronic total occlusion (cto).It was also reported that there was no tortuosity to the target vessel.The device was stored and prepped per the instructions for use (ifu) and maintained negative pressure during preparation.There was no difficulty removing the device from the hoop, removing the protective balloon cover, the stylet, or any of the sterile packaging components and the device was not kinked or damaged in any way prior to being inserted into the patient.The balloon was prepped with a 50/50 contrast and saline mixture.There was no resistance or friction experienced while inserting the device.There was no difficulty tracking towards the lesion and the device was able to cross the lesion.The device was never in an acute bend and did not kink during its use.After the rupture, the balloon catheter was able to be removed easily and remained in one piece during its removal.Information regarding the patient was requested but was not provided, and the device was discarded and will not be returned for evaluation.
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
Complaint conclusion: as reported, the balloon of an 8mm x 4cm 80cm powerflex extreme percutaneous transluminal angioplasty (pta) balloon catheter ruptured during its first intrastent inflation.As a result, a 9mm x 40mm non-cordis balloon catheter was used in place of the 8mm x 4cm 80cm powerflex extreme pta without issue to complete the procedure.There was no reported injury to the patient.This was during a procedure to treat in-stent restenosis of a previously placed stent at the venous anastomosis.The lesion had mild calcification, an 80% stenosis, and was non a chronic total occlusion (cto).It was also reported that there was no tortuosity to the target vessel.The device was stored and prepped per the instructions for use (ifu) and maintained negative pressure during preparation.There was no difficulty removing the device from the hoop, removing the protective balloon cover, the stylet, or any of the sterile packaging components and the device was not kinked or damaged in any way prior to being inserted into the patient.The balloon was prepped with a 50/50 contrast and saline mixture.There was no resistance or friction experienced while inserting the device.There was no difficulty tracking towards the lesion and the device was able to cross the lesion.The device was never in an acute bend and did not kink during its use.After the rupture, the balloon catheter was able to be removed easily and remained in one piece during its removal.Information regarding the patient 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 82232303 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst¿ could not be confirmed as the device was not returned for analysis.The exact cause of the reported event could not be determined.The vessel containing an implanted stent may have contributed to the reported event.Damage to balloon material may occur when attempting to cross a lesion with a stent already implanted.The stent struts may easily damage balloon material if caution is not met when attempting to cross.It is likely this was a contributing factor to the event reported along with the focal stenosis and calcification of the vessel.However, without the return of the device for analysis it is difficult to draw a clinical conclusion between the device and reported event.According to the safety information in the instructions for use ¿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: POWERFLEX EXTREME 8X4 80CM
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): COMPLAINT HANDLING; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 14221688
• Report Number: 3009018440-2022-00007
• Device Sequence Number: 4124178
• Product Code: LIT
• UDI-Device Identifier: 20705032001943
• UDI-Public: (01)20705032001943(17)240930(10)82232303
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K032737
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Model Number: 4158040S
• Device Catalogue Number: 4158040S
• Device Lot Number: 82232303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/01/2022
• Supplement Date Received by Manufacturer: 04/29/2022
• Initial Report FDA Received Date: 04/27/2022
• Supplement Report FDA Received Date: 05/06/2022
• Date Device Manufactured: 10/05/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GE OMNIPAQUE CONTRAST; MERIT FIRSTCHOICE 9X40 MM PTA BALLOON
• Patient Sex: Unknown