MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEX EXTREME 10X6 80CM; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 4150060S

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2022

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 82226909 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, two powerflex extreme 10x6 80cm balloon catheters leaked before reaching rated burst pressure (rbp).There was no patient injury as these balloon were tested for deflation time.The powerflex extreme currently is in china registration process.The test method is to inflate the balloon to rbp first and deflate it, and then record the deflation time as the test result.The product was stored properly according to the instructions for use (ifu).There was no difficulty noted while removing the product from the hoop.There was no difficulty removing the protective balloon cover, inner stylet, or any of the sterile packaging components.The device was prepped per the ifu.The device was prepped normally and was able to maintain negative pressure.The inflation device was filled with pure water and was used successfully with other devices.The powerflex extreme balloon was never on an acute bend.The devices will be returned for evaluation.

Event Description

As reported, two powerflex extreme 10x6 80cm balloon catheters leaked before reaching rated burst pressure (rbp).There was no patient injury as these balloon were tested for deflation time.The powerflex extreme currently is in china registration process.The test method is to inflate the balloon to rbp first and deflate it, and then record the deflation time as the test result.The product was stored properly according to the instructions for use (ifu).There was no difficulty noted while removing the product from the hoop.There was no difficulty removing the protective balloon cover, inner stylet, or any of the sterile packaging components.The device was prepped per the ifu.The device was prepped normally and was able to maintain negative pressure.The inflation device was filled with pure water and was used successfully with other devices.The powerflex extreme balloon was never on an acute bend.The devices will be returned for evaluation.

Manufacturer Narrative

As reported, two powerflex extreme 10x6 80cm balloon catheters leaked before reaching rated burst pressure (rbp).There was no patient injury as these balloons were being tested for deflation time.The powerflex extreme is currently in china registration process.The test method is to inflate the balloon to rbp first and deflate it, then record the deflation time as the test result.The product was stored properly according to the instructions for use (ifu).There was no difficulty noted while removing the product from the hoop.There was no difficulty removing the protective balloon cover, inner stylet, or any of the sterile packaging components.The device was prepped per the ifu.The device was prepped normally and was able to maintain negative pressure.The inflation device was filled with pure water and was used successfully with other devices.The powerflex extreme balloon was never on an acute bend.The device was returned for analysis.Two non-sterile powerflex extreme 10 x 6 80cm percutaneous transluminal angioplasty (pta) balloon catheters were received for analysis coiled inside a plastic bag under the complaints (b)(4).The units were randomly identified as unit number one and unit number two to perform the analysis.The identified unit as unit number one was analyzed under this complaint case-(b)(4).Per visual analysis of unit one, no anomalies were observed by the naked eye.Per functional testing, the unit was pre-inspected, and a lab sample syringe partially filled with water was attached to the inflation lumen on the hub and positive pressure applied, the unit leaked.The leakage was observed coming out from the guidewire lumen tip of the powerflex extreme 10x6 80 cm unit while inflating the device.It seems the water filling the balloon was leaking into the guidewire lumen.The balloon of the unit was cut off from the inner guide wire tubing and positive pressure was applied.A profuse leak was observed this time from a rupture on the guidewire lumen of the unit near the proximal marker band.Per microscopic analysis, the unit was sent to sem analysis to identify the possible root-cause.Results showed that the guidewire lumen of the unit was ruptured, causing the guidewire lumen leakage.The outer surface of the lumen presented holes near the rupture.The inner surface presented evidence damages; holes near the lumen rupture were observed.However, the exact cause of the observed holes on the guidewire lumen could not be conclusively determined during this analysis along with the pattern of apparent scratches found.No other anomalies were observed during the sem analysis.A product history record (phr) review of lot 82226909 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.It seems the water filling the balloon was leaking into the guidewire lumen.The balloon of the unit was cut off from the inner guide wire tubing and positive pressure was applied.A rupture was observed on the guidewire lumen of the unit near the proximal marker band.Per microscopic analysis, the unit was sent to sem analysis to identify the possible root-cause.Results showed that the guidewire lumen of the unit was observed ruptured, causing the guidewire lumen leakage.The outer surface of the lumen presented no anomalies near the rupture.The inner surface presented evidence damages; holes near the lumen rupture were observed.However, the exact cause of the observed holes on the guidewire lumen 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 82226909 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 for both products during device analysis; however, the exact cause could not be determined.A leakage of water was observed coming from the distal tip¿s guidewire lumen during functional analysis of the devices.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 guidewire lumen.Several factors are being considered and further investigation is required to find a definitive root cause.Therefore, based on the information available for review, it is difficult to draw a clinical conclusion between the device and the events reported as further investigation is warranted.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 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.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 has been initiated for further investigation.

• Brand Name: POWERFLEX EXTREME 10X6 80CM
• Type of Device: 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 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 13723004
• MDR Text Key: 292843229
• Report Number: 9616099-2022-05434
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032001561
• UDI-Public: (01)20705032001561(17)240731(10)82226909
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K032737
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4150060S
• Device Catalogue Number: 4150060S
• Device Lot Number: 82226909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: INFLATION DEVICE (FILLED WITH PURE WATER)