MAUDE Adverse Event Report: CORDIS CASHEL POWERFLEX P3 F5 6X4 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4206040S
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.This device was received for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.
Event or Problem Description
A 5f 6mm x 40mm x 80cm powerflex p3 percutaneous transluminal angioplasty (pta) balloon catheter was inflated one time and met its nominal inflation pressure, then leaked from the tip and would not inflate again when trying to treat the lesion.The product was removed intact in one piece from the patient.The procedure was completed with another balloon catheter.There was no reported patient injury.The intended procedure was angiogram declotting of the arteriovenous (av) fistulas.The target lesion was at the left arterial upper arm primarily the axillary arteriovenous (av) fistulas.The fistulas were noted to have a juxta-anastomotic segment (jxa) stenosis.The lesion had moderate calcification.The device was not used for a chronic total occlusion (total occlusion >3 months).The device was stored, handled and prepped as per the instruction for use (ifu).The device was stored as per the labeling and was opened in a sterile field.There was no damage noted to the packaging of the device prior to use.The device was prep normally and maintained negative pressure.There was no difficulty removing the product from the hoop and from the protective balloon cover.There was no difficulty removing the stylet or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product into the patient.The procedure used a non-cordis contrast media with 1 is to 1 contrast to saline ratio.The procedure used a syringe as an inflation device, and it was successfully used with other devices.Other additional procedural details were requested but are unknown.The device is expected to be returned for evaluation.
Additional Manufacturer Narrative
A 5f 6mm x 40mm x 80cm powerflex p3 percutaneous transluminal angioplasty (pta) balloon catheter was inflated one time and met its nominal inflation pressure.Leakage from the tip was noted and the balloon would not inflate again when trying to treat the lesion.There was no reported patient injury.The intended procedure was an angiogram with de-clotting of the arteriovenous (av) fistulas.The target lesion was at the left arterial upper arm primarily the axillary arteriovenous (av) fistulas.The fistulas were noted to have a juxta-anastomotic segment (jxa) stenosis.The lesion had moderate calcification.The device was not used for a chronic total occlusion (total occlusion >3 months).The procedure was completed with another balloon catheter.The device was stored, handled and prepped as per the instruction for use (ifu).The device was stored as per the labeling and was opened in a sterile field.There was no damage noted to the packaging of the device prior to use.The device was prepped normally and maintained negative pressure.There was no difficulty removing the product from the hoop, the protective balloon cover, the stylet or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product into the patient.The procedure used non-cordis contrast media with 1:1 contrast to saline ratio.The procedure used a syringe as an inflation device, and it was successfully used with other devices.The product was removed intact in one piece from the patient.Other additional procedural details were requested but are unknown.One product was returned for analysis.A non-sterile powerflex p3 f5 6x4 80 was received.Per visual analysis, the device was coiled inside a plastic bag and the balloon appears to have been previously inflated.The unit was thoroughly inspected at naked eye and no other anomalies were noted.Per functional analysis, balloon inflation was performed.A leakage of water was observed on the balloon¿s distal area during the inflation test.Per sem analysis, the balloon leakage was caused by a rupture on the balloon surface.The inner surface presented no anomalies near the rupture.The outer surface presented evidence of stress and scratch marks adjacent to 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 appears the balloon material near the rupture was torn 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 82178602 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 through analysis of the returned device.The exact cause of the leakage could not be determined.Device analysis revealed the balloons outer surface evidenced stress and scratch marks adjacent to the balloon 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 juxta-anastomotic segment which has moderate calcification and stenosis contributed to the event reported.The balloon catheter may have been induced to a tensile force that exceeded the material yield strength as evidenced by the stress/scratch marks noted upon device analysis.According to the instructions for use, which is not intended as a mitigation of risk, ¿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.(b)(4).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.¿ 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 6X4 80
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tipperary, 0000 ; EI 0000
• MDR Report Key: 9707396
• Report Number: 9616099-2020-03522
• Device Sequence Number: 19746348
• Product Code: LIT
• UDI-Device Identifier: 20705032004432
• UDI-Public: 20705032004432
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K032737
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2020

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: 08/31/2022
• Device Model Number: 4206040S
• Device Catalogue Number: 4206040S
• Device Lot Number: 82178602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2020
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 02/13/2020
• Supplement Report FDA Received Date: 03/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VISIPAQUE CONTRAST MEDIA & SYRINGE
• Patient Weight: 88