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

Model Number	4158040S
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the balloon of 8mm x 4cm x 80cm powerflex extreme percutaneous transluminal angioplasty (pta) balloon catheter was minimally inflated and leaked unknown contrast.Therefore, the balloon was removed, and another unknown balloon was used to complete the case.There was no reported patient injury.The balloon advanced over the unknown wire in patient¿s vessel.The physician attempted to inflate the balloons using a syringe with 50/50 saline and contrast ratio.The operator was trained to the powerflex extreme device.The device was prepped in sterile filed as per the instructions for use (ifu).There was no difficulty removing the product from the hoop, the protective balloon cover, or the stylet or any of the sterile packaging components.There were no kinks nor other damages noted prior to inserting the product into the patient.The device prepped normally (i.E.Maintain negative pressure).Ge omnipaque contrast media was used.The contrast to saline ratio was 50/50.A syringe inflation device was used.The same indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve, or while inserting the balloon through the guide catheter.The device was not used for a chronic total occlusion (total occlusion >3 months).There was no difficulty advancing the balloon catheter through the vessel.There was no difficulty crossing the lesion.The catheter was never in an acute bend.The balloon catheter did not kink while being used.The product was removed intact (in one piece) from the patient.The device will be returned for evaluation.
Additional Manufacturer Narrative
Complaint conclusion: as reported, the balloon of 8mm x 4cm x 80cm powerflex extreme percutaneous transluminal angioplasty (pta) balloon catheter was minimally inflated and leaked unknown contrast.Therefore, the balloon was removed, and another unknown balloon was used to complete the case.There was no reported patient injury.The balloon advanced over the unknown wire in patient¿s vessel.The physician attempted to inflate the balloon using a syringe with 50/50 saline and contrast ratio.The operator was trained to the powerflex extreme device.The device was prepped in sterile filed as per the instructions for use (ifu).There was no difficulty removing the product from the hoop, the protective balloon cover, or the stylet or any of the sterile packaging components.There were no kinks nor other damages noted prior to inserting the product into the patient.The device prepped normally (i.E.Maintain negative pressure).Non-cordis contrast media was used, the contrast to saline ratio was 50/50.A syringe inflation device was used.The same indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve, or while inserting the balloon through the guide catheter.The device was not used for a chronic total occlusion (total occlusion >3 months).There was no difficulty advancing the balloon catheter through the vessel.There was no difficulty crossing the lesion.The catheter was never in an acute bend.The balloon catheter did not kink while being used.The product was removed intact (in one piece) from the patient.One product was returned for analysis.A non-sterile powerflex extreme 8x4 80cm balloon catheter was received for analysis coiled inside a plastic bag.Per visual analysis, the balloon had been previously inflated.No anomalies could be observed at the naked eye.Per functional analysis, a syringe filled with water was attached to the inflation lumen and pressure was applied.However, a leakage was observed at the proximal balloon area of the powerflex.Per microscopic analysis, sem analysis was performed to the received balloon unit to identify the possible root cause of the leakage condition on the balloon with the following results: results showed that the balloon leakage was caused by a rupture on the balloon surface.The external surface of the balloon presented evidence of micro-tears and scratch marks near the balloon rupture.This type of damage is commonly caused during the interaction of the balloon material with a sharp object or mechanical damage.Likely, the same factors that caused the observed micro-tears and scratch marks on the balloon external surface probably lead to the ruptured condition found on the received balloon.The internal surface of the balloon did not present evidence of damages on the surrounding areas of the rupture.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 found during the analysis.No other anomalies were found during the analysis.A product history record (phr) review of lot 82191173 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 a leakage in the balloon on the proximal section of the balloon area.The balloon presented evidence of micro-tears and scratch marks near the balloon 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, although unknown, may have contributed to the reported event and damage to 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: POWERFLEX EXTREME 8X4 80CM
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 10579606
• Report Number: 9616099-2020-03924
• Device Sequence Number: 3449784
• Product Code: LIT
• UDI-Device Identifier: 20705032001943
• UDI-Public: 20705032001943
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K032737
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2020

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: 03/31/2023
• Device Model Number: 4158040S
• Device Catalogue Number: 4158040S
• Device Lot Number: 82191173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Initial Date Received by Manufacturer: 09/03/2020
• Supplement Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 09/24/2020
• Supplement Report FDA Received Date: 10/06/2020
• 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: UNK BALLOON CATHETER, UNK CONTRAST, UNK WIRE; UNK BALLOON CATHETER, UNK CONTRAST, UNK WIRE