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

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is related to report #9616099-2021-04223, 9616099-2021-04224, 9616099-2021-04225, and 9616099-2021-04440.When performing a shunt procedure, the balloon of three (3) 5mm x 4mm 80cm powerflex extreme percutaneous transluminal angioplasty (pta) balloon catheters were inflated; however, the balloons were blown, and the rated burst pressure (rbp) was not raised.¿as the balloon contracts in the state, the phenomenon of falling out continuously occurred, so a request from the hospital to recover the entire amount occurred.¿ there was no reported patient injury.The product was returned for analysis.A non-sterile powerflex extreme 5x4 80cm balloon catheter was returned from stock, received for analysis inside a plastic bag.The unit was returned already taken out from its original pouch/packaging box.Neither the inner pouch nor the outer packaging box of the unit was returned for evaluation.Functional testing was intended to be performed.The unit was pre-inspected, and a lab sample inflator-deflator was attached to the inflation lumen on the hub of the unit and positive pressure was applied.The unit failed the inflation test due to a leakage that was present on the proximal area of the balloon.Per microscopic analysis, the unit was sent to sem analysis to identify the possible root-cause of the leakage.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 balloons outer surface probably led to the ruptured condition found on the received device.It seems the balloon material near the rupture was torn due to the interaction of the balloon with a sharp object from the outside of the balloon.No other anomalies were observed during the sem analysis.Shipping of the unit and the way it was received for evaluation may have contributed to the observed condition.The damaged conditions may have occurred in transit since the devices were returned with the balloon covers removed from their original position and not in their sterile packaging.There was no lot number information provided due to the nature in which the devices were returned; therefore, a product history record (phr) review could not be generated.A ¿balloon-leakage- during positive pressure¿ was confirmed via device analysis for this unused device.A leakage was noted on the proximal area of the balloon.The outer surface of the balloon presented evidence of scratch marks near the balloon rupture.It is likely that the balloon was damaged and interacted with something rough or sharp.However, shipping of the unit and the way it was received for evaluation may have contributed to the observed condition.The damaged conditions may have occurred in transit since the devices were returned with the balloon covers removed from their original position and not in their sterile packaging.Therefore, it is difficult to draw a clinical conclusion between the device and the results of the analyzed product.Without a lot number to conduct a phr review, and the manner in which the device was returned for analysis, it is not possible to determine if the reported failure could be related to the manufacturing process.Therefore, no corrective or preventive actions will be taken at this time.
Event or Problem Description
When performing a shunt procedure, the balloon of three (3) 5mm x 4mm 80cm powerflex extreme percutaneous transluminal angioplasty (pta) balloon catheters were inflated; however, the balloons were blown, and the rated burst pressure (rbp) was not raised.¿as the balloon contracts in the state, the phenomenon of falling out continuously occurred, so a request from the hospital to recover the entire amount occurred.¿ there was no reported patient injury.The devices will be returned for evaluation, along with all other unused balloon catheters in stock.Addendum: during the product analysis of the unused balloon catheters returned, it was noted that a total of 4 additional devices had a shaft and/or balloon leakage.

• 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: 11695461
• Report Number: 9616099-2021-04441
• Device Sequence Number: 3073276
• Product Code: LIT
• UDI-Device Identifier: 20705032001684
• UDI-Public: 20705032001684
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K032737
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/20/2021

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 Model Number: N/A
• Device Catalogue Number: 4155040S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 04/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1