MAUDE Adverse Event Report: CORDIS CASHEL 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	07/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.This device was received for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.This is one of three products involved with the reported event.The medical device reporting reference number for these events are 9616099-2020-03829 and 9616099-2020-03828.
Event or Problem Description
As reported, the physician attempted hand inflation with 10cc syringe, using 50/50 contrast/saline ratio, however, the balloon of 5 x 4 x 80 powerflex extreme began to leak contrast and would not inflate to nominal.Therefore, the device was removed, and another balloon catheter (unknown) was opened to complete the case.There was no reported patient injury.The device was stored per labelling and opened in sterile field.The balloon was prepped as per instructions for use (ifu).There was no difficulty removing the product from the hoop, 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 the product into the patient.The device was placed over an unknown wire into the patient.The same indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or the guide catheter.The catheter ever has never been in an acute bend.There were damages noted to the balloon after it was removed from the patient.It was noted that the account has been having ongoing issues with this product.This event happened 2 times with different patients on the same day with the same lot #.The device will be returned for analysis.No other information was provided.
Additional Manufacturer Narrative
As reported, the physician attempted hand inflation with a 10cc syringe, using 50/50 contrast/saline ratio, however, the balloon of 5 x 4 x 80 powerflex extreme began to leak contrast and would not inflate to nominal.Therefore, the device was removed, and another balloon catheter (unknown) was opened to complete the case.There was no reported patient injury.The device was stored per labelling and opened in sterile field.The balloon was prepped as per instructions for use (ifu).There was no difficulty removing the product from the hoop, 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 placed over an unknown wire into the patient.The same indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or the guide catheter.The catheter ever has never been in an acute bend.There were damages noted to the balloon after it was removed from the patient.It was noted that the account has been having ongoing issues with this product.This event happened two times with different patients on the same day with the same lot number.No other information was provided.The device was returned for analysis.A non-sterile unit of a powerflex extreme 5 x 4 80cm was received for analysis coiled inside a plastic bag.Per visual analysis, the balloon had 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 test, results showed that the balloon leakage was caused by a rupture on the balloon surface.The inner surface presented no anomalies near the balloon rupture.The outer surface presented evidence of 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.It is very likely that the same factors that caused the observed scratch marks on the balloon outer surface probably led to the ruptured condition found on the received balloon.It seems 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 82179281 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 through analysis of the returned device as a leakage of water was observed coming from the balloon¿s proximal area.Analysis revealed the outer surface of the balloon presented evidence of 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, 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 5X4 80CM
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tipperary, 0000 ; EI 0000
• MDR Report Key: 10370142
• Report Number: 9616099-2020-03830
• Device Sequence Number: 2624590
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2020

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: 01/31/2023
• Device Model Number: 4155040S
• Device Catalogue Number: 4155040S
• Device Lot Number: 82179281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2020
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 08/19/2020
• Initial Report FDA Received Date: 08/05/2020
• Supplement Report FDA Received Date: 08/27/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN WIREUNKNOWN BALLOON CATHETER