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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 12MM4CM 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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CORDIS CORPORATION POWERFLEXPRO 12MM4CM 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 4401204S
Device Problems Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/15/2021
Event Type  Injury  
Event Description
As reported, the balloon of a 12mm x 4cm 80 powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter ruptured when taken above the rated burst pressure which caused the tip to break off from the catheter with half of the balloon on it.The portion that broke off was snared out of the patient.The balloon catheter was taken above the rated burst pressure on the instructions for use because there was a very tight lesion in subclavian vein per the physician.The maximum inflation pressures the balloon was taken to where it caused the device to burst was 12-14 atm as per the tech.No injury was caused to the patient.The intended procedure/target lesion was the subclavian vein.Vessel / lesion characteristics: the lesion had severe calcification.The percentage of stenosis was 95%.The vessel tortuosity and vessel angulation were unknown.It is unknown if the device was used for a chronic total occlusion (total occlusion >3 months).There were no anomalies noted when removed from the package or during prep.The device was used in the patient.The device was stored as per labeling and was opened in a sterile field.The device will be returned for evaluation.
 
Manufacturer Narrative
A review of the manufacturing documentation associated with this lot#82182452 presented no issues during the manufacturing process that can be related to the reported complaint.This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.
 
Manufacturer Narrative
As reported, the balloon of a 12mm x 4cm 80 powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter ruptured when taken above the rated burst pressure which caused the tip to break off from the catheter with half of the balloon on it.The portion that broke off was snared out of the patient.The balloon catheter was taken above the rated burst pressure on the instructions for use because there was a very tight lesion in subclavian vein per the physician.The maximum inflation pressures the balloon was taken to where it caused the device to burst was 12-14 atm as per the tech.There was no patient injury.The intended procedure/target lesion was the subclavian vein.The lesion had severe calcification and the percentage of stenosis was 95%.The vessel tortuosity and vessel angulation were unknown.It is also unknown if the device was used for a chronic total occlusion (total occlusion >3 months).There were no anomalies noted when removed from the package or during prep.The device was used in the patient.The device was stored as per labeling and was opened in a sterile field.The product was returned for analysis.A non-sterile powerflex pro 12mm x 4cm 80 percutaneous transluminal angioplasty (pta) balloon catheter involved in the complaint was received for analysis inside a plastic bag.Per visual analysis, the powerflex pro was received with the balloon separated at the distal area.Dried blood residues were observed on the unit.No other physical characteristics could be seen.Per microscopic analysis, the separated area of the unit was inspected under the pal vision system and the edges on the separated inner body were observed twisted and elongated.Also, the body shaft of the unit near the separation was observed kinked/compressed with a reduction in body shaft diameter and elongated.The observed separated area presented evidence of material elongations, which are commonly associated with separations caused by material tensile overload.Also, diameter reduction was observed.The elongations found on the body shaft material, as well as the diameter reduction, are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the body shaft material was induced to a tensile force that exceeded the body shaft material yield strength prior to the separation.Sem analysis was also performed, 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 could have probably led to the ruptured 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 82182452 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst-above rbp¿ and ¿distal tip - separated - in-patient¿ were confirmed through analysis of the returned device.The exact cause of the events cannot be determined.The device was received separated, the edges on the separated inner body were twisted and elongated.The body shaft of the unit near the separation was also kinked, compressed, elongated, and showed a reduction in body shaft diameter.These damages found on the body/shaft material are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the body/shaft material was induced to a tensile force that exceeded the body/shaft material yield strength prior to the material separation.The balloon material was also observed ruptured and 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.It was also noted the device was inflated beyond its rbp, (eight atmospheres) and is listed in the compliance card as such.Therefore, based on the information available the device was induced to events exceeding its material yield strength for the balloon material and the body/shaft material resulting in the failures reported by the customer.According to the safety information in the instructions for use ¿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) of the balloons (with a (b)(4) 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.Pressure in excess of the rated burst pressure can cause balloon rupture and potential inability to withdraw the catheter through the introducer sheath.Balloon rupture can cause vessel damage and the need for additional intervention.Proper functioning of the catheter depends on its integrity.Care should be used when handling the catheter.Damage may result from kinking, stretching, or forceful wiping of the catheter.Forceful handling can result in catheter separation and the subsequent need to use a snare or other medical interventional techniques to retrieve the pieces.Always verify integrity of the catheter after removal.¿ 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.
 
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Brand Name
POWERFLEXPRO 12MM4CM 80
Type of Device
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
MDR Report Key12605311
MDR Text Key281131175
Report Number9616099-2021-04916
Device Sequence Number1
Product Code LIT
UDI-Device Identifier20705032060179
UDI-Public20705032060179
Combination Product (y/n)N
PMA/PMN Number
K112797
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/30/2022
Device Model Number4401204S
Device Catalogue Number4401204S
Device Lot Number82182452
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/24/2021
Date Manufacturer Received10/21/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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