MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 6MM22CM 135; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number 4400622X

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/21/2019

Event Type  malfunction  

Manufacturer Narrative

The balloon of a 6mm x 22cm 135cm powerflex pro ruptured at six atmospheres (atm) and failed to deflate properly inside of the patient.There was no reported injury.The device was used for chronic total occlusion (cto) after an atherectomy was done.The superficial femoral artery (sfa) had severe calcification with no vessel tortuosity.Prior to use, the device was stored in the cath lab inside a cart three months.The device was stored, handled and prepped normally (i.E.Maintained negative pressure) per instructions for use (ifu).There was no difficulty removing the product from the hoop, the protective balloon cover, the stylet or any of the sterile packaging components.The product was inspected prior to use and no defects were noted.Prior to using the powerflex pro, a non-cordis catheter sheath introducer (csi) atherectomy device was used on the target lesion.There was no resistance or friction felt while inserting the balloon through the rotating hemostatic valve or through the guide catheter.The catheter was not in acute bend and the balloon catheter was removed easily.No unusual force was used at any time during the procedure.There was leakage noted from the balloon during the procedure and after it was removed.The device was removed from the patient in one piece.Negative pressure was pulled repeatedly with a non-cordis indeflator and then a 20cc syringe was used to assist it.The balloon was eventually deflated enough to pull it back into an unknown 6f sheath and was removed from the patient.The device was not returned for evaluation as the device was discarded.A product history record (phr) review of lot 82169103 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, such as severe calcification, may have contributed to the reported event.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 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.

Event Description

As reported, the balloon of a 6mm x 22cm 135 powerflex pro ruptured and failed to deflate properly inside of a patient after initial inflation to 6 atmospheres (atm).There was no reported injury.Prior to use, the device was stored in the cath lab inside a cart and was stored for less than 3 months.The device was stored, handled and prepped as per instructions for use (ifu).It was prepped normally and used negative pressure.There was no difficulty noted when removing the stylet or any components of the sterile packaging.There was no difficulty removing the product from the hoop.There was no difficulty when removing the balloon cover.The product was inspected prior to use and it appeared to be normal.There were no kinks or damages prior to insertion to the patient.There was no resistance or friction felt while inserting the balloon through the rotating hemostatic valve and through the guide catheter.No unusual force was used at any time during the procedure.There was leakage noticed from the balloon during the procedure and after it was removed.There was no tortuosity on the vessel noted.The device was used for chronic total occlusion (cto) after the atherectomy was done.The catheter was not in acute bend.The balloon catheter was removed easily.The device was removed from the patient in one piece.Negative pressure was pulled repeatedly with a non-cordis indeflator and then a 20cc syringe was used to assist it.The balloon was eventually deflated enough to pull it back into an unknown 6f sheath and was removed from the patient.The superficial femoral artery (sfa) had severe calcification.Prior to using the powerflex pro, a non-cordis catheter sheath introducer (csi) atherectomy device was used on the target lesion.The device will not be returned for evaluation as it was already disposed.

• Brand Name: POWERFLEXPRO 6MM22CM 135
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 9343960
• MDR Text Key: 198969023
• Report Number: 9616099-2019-03360
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032059647
• UDI-Public: 20705032059647
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112797
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 4400622X
• Device Lot Number: 82169103
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/21/2019
• Date Device Manufactured: 04/15/2019
• 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
• Patient Age: 70 YR
• Patient Weight: 136