MAUDE Adverse Event Report: CORDIS DE MEXICO POWERFLEXPRO 7MM4CM 135; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number N/A

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2019

Event Type  malfunction  

Manufacturer Narrative

The device was returned but the engineering report is pending.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the balloon of 7mm x 40mm x 135cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter (bc) was ruptured at nominal inflation pressure.Therefore, the product was removed intact (in one piece) from the patient.The procedure was completed with the used of another balloon.There was no reported patient injury.The intended procedure was percutaneous transluminal angioplasty (pta).The target lesion was the superficial femoral artery (sfa).The 80% occluded lesion was calcified and had moderate vessel tortuosity.The device was not used for a chronic total occlusion (total occlusion >3 months).There was no difficulty removing the stylet or any of the sterile packaging components.There was no difficulty removing the product from the hoop.There was no difficulty removing the protective balloon cover.There were no kinks or other damages noted prior to inserting the product into the patient.The device was prep normally and negative pressure was maintained.The contrast had a 1:2 saline ratio.The same indeflator was used successfully with other devices.There was no resistance or friction while inserting the balloon through the rotating hemostatic valve and through the guide catheter.The catheter was not ever in an acute bend.There was difficulty crossing the lesion and advancing the balloon catheter through the vessel.The device is expected to be returned for evaluation.

Manufacturer Narrative

The balloon of 7mm x 40mm x 135cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter (bc) ruptured at nominal inflation pressure.There was no reported patient injury.The intended procedure was a percutaneous transluminal angioplasty (pta).The target lesion was the superficial femoral artery (sfa).The 80% occluded lesion was calcified and had moderate vessel tortuosity.The device was not used for a chronic total occlusion (total occlusion >3 months).There was no difficulty removing the product from the hoop, the protective balloon cover, the 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 normally, and negative pressure was maintained.The contrast had a 1:2 saline ratio.The same indeflator was used successfully with other devices.There was no resistance or friction while inserting the balloon through the rotating hemostatic valve or through the guide catheter.The catheter was never in an acute bend.There was difficulty crossing the lesion and advancing the balloon catheter through the vessel.The product was removed intact (in one piece) from the patient.The procedure was completed with the use of another balloon catheter.The product was returned for analysis.A non-sterile powerflex pro 7mm x 4cm 135cm was received for analysis coiled inside a plastic bag.Per visual analysis, the balloon looked like it had been previously inflated.Blood residue was observed inside the balloon.The unit was thoroughly inspected at naked eye and no other anomalies were observed.Per functional analysis, balloon inflation was performed.Blood residues on balloon were washed out before inflation test.A leakage of water was observed on the balloon¿s distal area during the inflation test.Per sem analysis, the balloon leakage was caused by a rupture on the balloon surface.The inner surface presented bulged/peeled off material along the rupture.The outer surface presented evidence of bulged/peeled off material and scratch marks adjacent to the balloon rupture.This type of damage is commonly caused during the interaction of the balloon material with a sharp object or mechanical damage.It appears the balloon material near the rupture was torn with a sharp object from the outside of the balloon.No other anomalies were observed during the sem analysis.A product history record (phr) review of lot 17672542 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¿ was confirmed through analysis of the returned device.The exact cause of the balloon burst could not be determined.Based on the information available for review, vessel characteristics, such as calcification with moderate vessel tortuosity likely contributed to the reported event as evidenced by scratch marks and bulged/peeled material adjacent to the rupture.It is known that calcium may damage balloon material.According to the safety information in the instructions for use (ifu), which is not intended as a mitigation of risk, ¿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 review nor the product analysis suggests that the reported failure could be related to the manufacturing process of unit.Therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: POWERFLEXPRO 7MM4CM 135
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• MDR Report Key: 9458113
• MDR Text Key: 199107129
• Report Number: 9616099-2019-03398
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032059708
• UDI-Public: 20705032059708
• Combination Product (y/n): N
• PMA/PMN Number: K112797
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/31/2019

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: 04/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 4400704X
• Device Lot Number: 17672542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Initial Date Manufacturer Received: 11/18/2019
• Initial Date FDA Received: 12/12/2019
• Supplement Dates Manufacturer Received: 12/20/2019
• Supplement Dates FDA Received: 12/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1