MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 7MM4CM 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 4400704S

Device Problem Burst Container or Vessel (1074)

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

Event Date 06/08/2022

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 82235789 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the powerflex pro 7mm 4cm was used; however, the balloon ruptures at 8atm (below rbp).The case was completed after an unknown 6mm balloon was used, which was used in another lesion.There was no reported injury to the patient.The lesion was in the iliac.The device was stored properly according to the instructions for use (ifu).There was no difficulty removing the product from the hoop, removing the protective balloon cover, stylet, or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product into the patient.The device was prepped per the ifu.The device prepped normally and was able to maintain negative pressure.The lesion was noted to have moderate calcification.The vessel had mild tortuosity.The lesion was noted to have a 90% stenosis; however, the device was not being used to treat a chronic total occlusion (cto).The balloon did not rupture while in a stent.There was no resistance/friction noted while inserting the balloon through the rotating hemostatic valve or while inserting through the guide catheter.The balloon catheter advanced through the vessel without difficulty.There was no difficulty crossing the lesion.The catheter was never in an acute bend and was never kinked while being used.The device was removed intact (in one piece).The device was discarded and will not be returned for evaluation.

Event Description

As reported, the powerflex pro 7mm 4cm was used; however, the balloon ruptures at 8atm (below rbp).The case was completed after an unknown 6mm balloon was used, which was used in another lesion.There was no reported injury to the patient.The lesion was in the iliac.The device was stored properly according to the instructions for use (ifu).There was no difficulty removing the product from the hoop, removing the protective balloon cover, stylet, or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product into the patient.The device was prepped per the ifu.The device prepped normally and was able to maintain negative pressure.The lesion was noted to have moderate calcification.The vessel had mild tortuosity.The lesion was noted to have a 90% stenosis; however, the device was not being used to treat a chronic total occlusion (cto).The balloon did not rupture while in a stent.There was no resistance/friction noted while inserting the balloon through the rotating hemostatic valve or while inserting through the guide catheter.The balloon catheter advanced through the vessel without difficulty.There was no difficulty crossing the lesion.The catheter was never in an acute bend and was never kinked while being used.The device was removed intact (in one piece).The device was discarded and will not be returned for evaluation.

Manufacturer Narrative

The powerflex pro 7mm x 4cm was used; however, the balloon ruptures at 8atm (eight atmospheres) (below rbp).The case was completed after an unknown 6mm balloon was used, which was used in another lesion.The lesion was in the iliac.The lesion was noted to have moderate calcification.The vessel had mild tortuosity.The lesion was noted to have a 90% stenosis; however, the device was not being used to treat a chronic total occlusion (cto).There was no reported injury to the patient.The device was stored properly according to the instructions for use (ifu).There was no difficulty removing the product from the hoop, removing the protective balloon cover, stylet, or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product into the patient.The device was prepped per the ifu.The device prepped normally and was able to maintain negative pressure.The balloon did not rupture while in a stent.There was no resistance/friction noted while inserting the balloon through the rotating hemostatic valve or while inserting through the guide catheter.The balloon catheter advanced through the vessel without difficulty.There was no difficulty crossing the lesion.The catheter was never in an acute bend and was never kinked while being used.The device was removed intact (in one piece).The product was not returned for analysis.A product history record (phr) review of lot 82235789 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 could not be determined.Vessel characteristics of moderate calcification and a rate of stenosis of 90% may have contributed to the reported event.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 limited information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: POWERFLEXPRO 7MM4CM 80
• 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: 14888172
• MDR Text Key: 295154332
• Report Number: 9616099-2022-05771
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032059821
• UDI-Public: (01)20705032059821(17)241130(10)82235789
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 07/08/2022

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 Model Number: 4400704S
• Device Catalogue Number: 4400704S
• Device Lot Number: 82235789
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/08/2022
• Initial Date FDA Received: 07/01/2022
• Supplement Dates Manufacturer Received: 07/05/2022
• Supplement Dates FDA Received: 07/08/2022
• Date Device Manufactured: 12/03/2021
• 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: E-CHARGE (ABT)-INFLATION DEVICE; UNK BALLOON CATHETER