MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEX EXTREME 5X4 80CM; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4155040S
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.Additional information is pending and will be submitted within 30 days upon receipt.This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.This is one of two reports submitted for the same event.
Event or Problem Description
As reported, the balloon of the two (2) 5mm x 4cm x 80cm powerflex extreme percutaneous transluminal angioplasty (pta) balloon catheter minimally inflated, and leaked unknown contrast.Therefore, the balloons were removed, and another unknown balloon was used to complete the case.There was no reported patient injury.The balloons advanced over the unknown wire into 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 devices were stored as per labeling, and 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 devices will be returned for evaluation.
Additional Manufacturer Narrative
This is one of two reports submitted for the same event.Please reference mfr report #: 9616099-2020-03931.Complaint conclusion: as reported, the balloon of the two (2) 5mm x 4cm x 80cm powerflex extreme percutaneous transluminal angioplasty (pta) balloon catheters minimally inflated and leaked unknown contrast.Therefore, the balloons were removed, and another unknown balloon was used to complete the case.There was no reported patient injury.The balloons advanced over the unknown wire into 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 devices were stored as per labeling and 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, 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.(b)(4) the device was returned for analysis.A non-sterile unit of a powerflex extreme 5 x 4 80cm was received for analysis under this complaint.The unit was received coiled inside a plastic bag.Per visual analysis of the unit received, the balloon had been previously inflated and blood residues were observed inside the balloon.The unit was thoroughly inspected at naked eye and no other anomalies were observed.Per functional analysis, balloon inflation test was performed on the non-sterile unit received.The balloon could not be inflated at first, a cross-section analysis was performed, and saline solution crystals were observed on the inflation lumen.Then the crystals were removed, and the balloon was inflated successfully at 20 atm (device¿s rated burst pressure) with the inflator device; neither a leakage nor a burst was observed on the balloon.A product history record (phr) review of lot 82179274 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 not confirmed through analysis of the returned device.The exact cause of the reported leakage could not be determined.Per functional analysis of the balloon, there was no leakage or rupture noted upon inflation during functional analysis.The device performed as intended and maintained positive pressure at 20atm the device¿s rbp.It is likely that procedural factors and handling of the device contributed to the event reported by the customer.Therefore, based on the information available for review it is likely the dried contrast crystals prevented the balloon to inflate properly.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 5X4 80CM
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 10580919
• Report Number: 9616099-2020-03929
• Device Sequence Number: 11553762
• Product Code: LIT
• UDI-Device Identifier: 20705032001684
• UDI-Public: 20705032001684
• 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): 10/14/2020

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: 09/30/2022
• Device Model Number: 4155040S
• Device Catalogue Number: 4155040S
• Device Lot Number: 82179274
• 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: 10/06/2020
• Initial Report FDA Received Date: 09/24/2020
• Supplement Report FDA Received Date: 10/14/2020
• 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