MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 3MM15CM 135; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 4400315X

Device Problem Burst Container or Vessel (1074)

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

Event Date 10/01/2021

Event Type  malfunction  

Manufacturer Narrative

As reported, during a peripheral angioplasty the powerflex pro 3mm x 15cm 135 balloon catheter did not inflate.The doctor noticed that the balloon was punctured.The puncture/cut noticed was noted during use.There was no patient injury.Another powerflex balloon was used without problems.The target and access site were femoral.The device was prepped per the ifu.There was no difficulty experienced when prepping the device.A contralateral approach was not used.The device was not being used for treatment of a chronic total occlusion.The product, or any of the other devices used were not resterilized.The product was returned for analysis.One non-sterile powerflex pro 3mm x 15cm 135 percutaneous transluminal angioplasty (pta) balloon catheter was received for analysis inside a clear plastic bag.Per visual analysis, the balloon profile was inspected, and it appears to have been previously inflated.No anomalies in the balloon were noted by the naked eye.Functional analysis was performed on the unit.A lab sample inflator/deflator device partially filled with water was attached to the inflation lumen of the unit and positive pressure was applied.A leakage was observed in the body shaft area of the unit near the balloon proximal seal.Per microscopic analysis, a torn condition on the body shaft was observed near the proximal seal area.The unit was sent to sem analysis to identify the possible root cause of the torn body shaft.Results showed that the leakage was due to a tear on the body/shaft caused by a rupture on the body/shaft area.The outer surface presented evidence of scratch marks near the body/shaft area rupture.This type of damage is commonly caused during the interaction of the body/shaft material with a sharp object or mechanical damage.It is very likely that the same factors that caused the observed scratch marks on the body/shaft area surface probably led to the ruptured condition found on the received device.It seems the body/shaft material near the rupture was torn either due to the interaction of the body/shaft with calcified spicules located on the lesion or with a sharp object from the outside of the body/shaft.No other anomalies were observed during the sem analysis.A product history record (phr) review of lot 82207661 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon frayed/ split/torn - in-patient¿ was not confirmed during device analysis.However, a subsequent failure of ¿body/shaft burst¿ was confirmed during analysis.A rupture was observed on the body/shaft near the proximal seal.The exact cause of the damage could not be determined.The outer surface of the shaft presented evidence of scratch marks adjacent to the rupture noted and appears to have been torn either due to the interaction of the device with calcified spicules located on the lesion or with a sharp object from the outside of the shaft.It is likely vessel characteristics and procedural factors, contributed to the reported event as evidenced by device analysis.According to the safety information in the instructions for use, ¿if resistance is met during manipulation, determine the cause of the resistance before proceeding.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.Note: balloon inflation should be performed with the guidewire extended beyond the catheter tip.It is strongly recommended that the guidewire, the balloon catheter, or both, remain across the lesion until the procedure is complete and the dilatation system is to be removed from the vessel.Prior to angioplasty, the catheter should be examined to verify functionality and integrity, and ensure that its size and shape are suitable for the specific procedure for which it is to be used.Do not use if product damage is evident.¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action will be taken at this time.

Event Description

As reported, during a peripheral angioplasty the powerflexpro 3mm15cm 135 balloon catheter did not inflate.The doctor noticed that the balloon was punctured.The puncture /cut noticed was noted during use.There was no patient injury.Another powerflex was used without problems.The target and access site were femoral.The device was prepped per the ifu.There was no difficulty experienced when prepping the device.A contralateral approach was not used.The device was not being used for treatment of a chronic total occlusion.The product, or any of the other devices used were not resterilized.The device was not returned for evaluation.

• Brand Name: POWERFLEXPRO 3MM15CM 135
• 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: 13686198
• MDR Text Key: 292843741
• Report Number: 9616099-2022-05403
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032059098
• UDI-Public: (01)20705032059098(17)231031(10)82207661
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K112797
• 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
• Report Date: 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 4400315X
• Device Catalogue Number: 4400315X
• Device Lot Number: 82207661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2020
• 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: POWERFLEX BALLOON