MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEX EXTREME 6X4 80CM; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4156040S
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
As reported, the powerflex extreme 6x4 ruptured while the pressure was raised during inflation of the balloon.Therefore, the balloon could not be used.There was no reported injury to the patient.The procedure being performed was an arteriovenous fistulagram (avf) with pta.The device will be retuned for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b4, d4, g3, h1, h2, h3 and h6.As reported, the powerflex extreme 6 x 4 ruptured while the pressure was raised during inflation of the balloon.Therefore, the balloon could not be used.There was no reported injury to the patient.The procedure being performed was an arteriovenous fistulagram (avf) with pta.The product was returned for analysis.One non-sterile powerflex extreme 6 x 4 80cm balloon catheter was received for analysis inside a plastic bag.Per visual analysis, no anomalies were detected by the naked eye.Per functional analysis, 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.A leakage was observed coming out from the guidewire lumen tip of the powerflex extreme unit while inflating the device.It seems the water filling the balloon was leaking into the guidewire lumen.The unit was then thoroughly inspected and a rupture on the guidewire lumen was observed near the proximal seal, between the proximal seal and the marker band area.Per microscopic analysis, sem was performed; results showed that the guidewire tubing of the unit was had two ruptured conditions.The outer surface of the component presented scratch marks near one of the ruptures found.This type of damage is commonly caused during the interaction of the material with a sharp object or mechanical damage.It is very likely that the same factors that caused the observed scratch marks on the material could probably led to one of the ruptured conditions found.The other rupture presented holes.However, the exact cause of the observed holes on the guidewire tubing could not be conclusively determined during this analysis.No other anomalies were observed during the sem analysis.A product history record (phr) review of lot 82193031 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst - at/below rbp¿ was not confirmed via device analysis as there were no anomalies noted on the balloon material.However, a leakage of water was observed coming from the distal tip¿s guidewire lumen.The exact cause of the event could not be determined.It is likely that the guidewire lumen was damaged and interacted with something rough or sharp which caused the noted holes on the inner wall of the guidewire lumen adjacent to the ruptured area on the balloon catheter.Based on the information available for review, it is difficult to draw a clinical conclusion between the device and the events reported.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.Flush the ¿thru¿ lumen with sterile heparinized saline or a similar isotonic solution.Place the prepared catheter over a prepositioned guidewire and advance the tip to the introduction site.Carefully advance the catheter to the selected stenosis.Caution: if strong resistance is met during advancement or withdrawal of the catheter, discontinue movement and determine the cause of resistance before proceeding.If the cause of resistance cannot be determined, withdraw the entire system.Balloon pressure should not exceed the rated burst pressure.The rated burst pressure is based on the results of in-vitro testing.At least (b)(4) 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.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.¿ the product analysis suggests that the event experienced by the customer may be associated to the manufacturing process.Therefore, a risk assessment and capa were initiated for further investigation.
Event or Problem Description
As reported, the powerflex extreme 6x4 ruptured while the pressure was raised during inflation of the balloon.Therefore, the balloon could not be used.There was no reported injury to the patient.The procedure being performed was an arteriovenous fistulagram (avf) with pta.The device will be retuned for evaluation.Multiple attempts were made without success to obtain additional information.

• Brand Name: POWERFLEX EXTREME 6X4 80CM
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 15109152
• Report Number: 3009018440-2022-00013
• Device Sequence Number: 20147502
• Product Code: LIT
• UDI-Device Identifier: 20705032001752
• UDI-Public: (01)20705032001752(17)230430(10)82193031
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2022

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: 04/30/2023
• Device Model Number: 4156040S
• Device Catalogue Number: 4156040S
• Device Lot Number: 82193031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2022
• Supplement Date Received by Manufacturer: 07/25/2022
• Initial Report FDA Received Date: 07/26/2022
• Supplement Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown