MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 12MM6CM 135; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4401206X
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82157376 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.
Event or Problem Description
As reported, the balloon of 12mm x 6cm 135 powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter was found leaking and cannot be filled with pressure when it was being pressurized using a pressure pump.There was no reported patient injury.The target vessel was the iliac vein.The lesion was not calcified or tortuous.The percentage of stenosis was 80%.The device was not used for a chronic total occlusion (total occlusion >3 months.There was no difficulty removing the product from the hoop or removing the protective balloon cover.There was no difficulty removing the stylet or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product the product into the patient.The device did not prep normally.The contrast to saline ration was 1:1 and a non cordis inflation device was used.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or while inserting the balloon through the guide catheter.There was no difficulty advancing the balloon catheter through the vessel or crossing the lesion.The catheter was never in an acute bend.The plunger depressed into the syringe/indeflator when trying to inflate.There was no leakage noted from the balloon, shaft, hub, or unknown segment.Maximum inflation pressure was 0 atmospheres (atm).The product was removed intact from the patient.Other procedural details were requested but are unknown or unavailable.The device will be returned for evaluation.
Additional Manufacturer Narrative
As reported, the balloon of 12mm x 6cm 135 powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter was found leaking and cannot be filled with pressure when it was being pressurized using a pressure pump.There was no reported patient injury.The target vessel was the iliac vein.The lesion was not calcified or tortuous.The percentage of stenosis was 80%.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 did not prep normally.The contrast to saline ratio was 1:1 and a non-cordis inflation device was used.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or while inserting the balloon through the guide catheter.There was no difficulty advancing the balloon catheter through the vessel or crossing the lesion.The catheter was never in an acute bend.The plunger depressed into the syringe/indeflator when trying to inflate.There was no leakage noted from the balloon, shaft, hub, or unknown segment.Maximum inflation pressure was 0 atmospheres (atm).The product was removed intact from the patient.Other procedural details were requested but are unknown or unavailable.The device was returned for analysis.One non-sterile powerflex pro 12mm x 6cm 135 was received for analysis coiled inside a plastic bag.Per visual analysis, the balloon appears to have been previously inflated.The unit was thoroughly inspected at naked eye and no other anomalies were observed.Per functional analysis, balloon inflation was performed.A lab inflator/deflator device was attached to the inflation lumen of unit and pressure applied.A leakage of water was observed on the balloon¿s proximal area.Per sem analysis on the balloon leakage observed during inflation testing; results revealed the balloon leakage was caused by a rupture on the balloon surface.The inner surface presented no anomalies adjacent to 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 is very likely that the same factors that caused the observed bulged/peeled off material and scratch marks on the balloon outer surface most likely led to the ruptured condition found on the received device.It appears the balloon material near the rupture was torn either due to the interaction of the balloon with calcified spicules located on the lesion or 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 82157376 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon leakage - during positive pressure¿ was confirmed by device analysis; however, the exact cause could not be determined.Analysis revealed the outer surface of the balloon presented evidence of bulged/peeled off material and scratch marks adjacent to the rupture.The balloon appears to have been torn by calcified spicules, or a sharp object from the outside of the balloon.It is likely that vessel characteristics of 80% stenosis may have contributed to the reported event and damage balloon material occurred.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.To reduce the potential for vessel damage, the inflated diameter of the balloon should approximate the diameter of the vessel just proximal and distal to the stenosis.When the catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation.Do not advance or retract the catheter unless the balloon is fully deflated under vacuum.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.¿ neither the phr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process.Therefore, no corrective or preventive action will be taken at this time.

• Brand Name: POWERFLEXPRO 12MM6CM 135
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 10250181
• Report Number: 9616099-2020-03780
• Device Sequence Number: 2577048
• Product Code: LIT
• UDI-Device Identifier: 20705032072806
• UDI-Public: 20705032072806
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K112797
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2020

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: 07/31/2021
• Device Model Number: 4401206X
• Device Catalogue Number: 4401206X
• Device Lot Number: 82157376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Initial Date Received by Manufacturer: 06/12/2020
• Supplement Date Received by Manufacturer: 06/12/2020
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 07/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BOSTON INFLATION DEVICE.; UNK PRESSURE PUMP.
• Patient Weight: 65