MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEX P3 F5 8X4 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number 4208040S

Device Problems Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/13/2022

Event Type  Injury  

Manufacturer Narrative

This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the balloon of an 8mm x 4cm 80cm powerflex p3 percutaneous transluminal angioplasty (pta) balloon catheter ruptured while ballooning a tight lesion within a fistula.The rupture caused the balloon to separate into two pieces and a portion of the balloon was left inside the patient upon removal of the powerflex p3 pta balloon catheter.The left-over portion of the balloon was eventually removed from the patient; however, there was a lot of bleeding, and an unknown covered stent was placed.The patient is now discharged.The device prepped normally and was able to maintain negative pressure.There wasn¿t any difficulty removing the stylet or any of the sterile packaging components and there were no kinks or other damages noted prior to inserting the product into the patient.There was no calcification at the target site, but mild tortuosity was present in the target vessel.The balloon was not being used to post dilate a previously placed stent.Information regarding the removal of the separated balloon segment, contrast media, contrast to saline ratio, inflation pressure, covered stent implantation, bleeding, and possible vessel damage was requested but is unavailable.The device will be returned for evaluation.

Manufacturer Narrative

As reported, the balloon of an 8mm x 4cm 80cm powerflex p3 percutaneous transluminal angioplasty (pta) balloon catheter ruptured while ballooning a tight lesion within a fistula.The rupture caused the balloon to separate into two pieces and a portion of the balloon was left inside the patient upon removal of the powerflex p3 pta balloon catheter.The left-over portion of the balloon was eventually removed from the patient; however, there was a lot of bleeding, and an unknown covered stent was placed.The patient is now discharged.The device prepped normally and was able to maintain negative pressure.There was no difficulty removing the stylet or any of the sterile packaging components and there were no kinks or other damages noted prior to inserting the product into the patient.There was no calcification at the target site, but mild tortuosity was present in the target vessel.The balloon was not being used to post dilate a previously placed stent.Information regarding the removal of the separated balloon segment, contrast media, contrast to saline ratio, inflation pressure, covered stent implantation, bleeding, and possible vessel damage was requested but is unavailable.One product was returned for analysis.A non-sterile powerflex p3 f5 8x4 (b)(4) was received for analysis coiled inside a plastic bag.Per visual analysis, the balloon was observed separated approximately at the proximal area of the balloon.No other anomalies were observed.Per sem analysis on the separated balloon observed during the visual review, results showed that the balloon separation 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 rupture condition found on the received device.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 82206888 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst¿ and ¿balloon separated - in-patient¿ were confirmed through analysis of the returned device.However, the exact cause of the burst/separation could not be determined.Device analysis revealed scratch marks on the balloons outer surface adjacent to the rupture.This type of damage is commonly caused when balloon material encounters a sharp object or mechanical damage.It is likely that vessel characteristics of the fistula contributed to the events reported as evidenced by device analysis.The balloon material was likely induced to a tensile force that exceeded the material yield strength prior to the separation.Arteriovenous shunts are often scarred and fibrous in nature and are therefore, often resistant to balloon expansion increasing the likelihood of damage to the balloon.Risks associated with angioplasty procedures include bleeding which is a well-known and extensively documented potential complications of this type of procedure.Vessels that are resistant to angioplasty have a higher risk of intimal plaque rupture during interventional procedures which may have contributed to the bleeding reported.A resistant lesion can cause damage to the balloon and may result in vessel damage during angioplasty.Review of the available information suggests that lesion characteristics and possibly procedural factors may have contributed to the balloon burst/separation and bleeding.However, we do not know what the anticoagulant/antiplatelet status of the patient was at the time of the event as this information was not provided.Therefore, we can conclude the anticoagulation status of the patient may have also been a contributing factor to the bleeding reported by the customer.According to the instructions for use, which is not intended as a mitigation of risk, ¿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.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(b)(4), 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.According to the possible adverse effects listed in the ifu include, but are not limited to, the following: air embolism, aneurysm, hematoma at the puncture site, and perforation of the vessel wall.¿ 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 P3 F5 8X4 80
• 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: 13513707
• MDR Text Key: 287558905
• Report Number: 9616099-2022-05339
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032737
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 4208040S
• Device Lot Number: 82206888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2022
• Initial Date FDA Received: 02/11/2022
• Supplement Dates Manufacturer Received: 02/13/2022
• Supplement Dates FDA Received: 02/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2020
• 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: UNKNOWN COVERED STENT.
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female