MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEX P3 F5 12X4 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4202040S
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, there was a leak at the distal balloon tip of a 12mm x 4cm 80cm powerflex p3.035 percutaneous transluminal angioplasty (pta) balloon catheter.As a result, a new 12mm x 4cm 80cm powerflex p3 pta balloon catheter was successfully used in place of the leaking 12mm x 4cm 80cm powerflex pta balloon catheter.There was no reported injury to the patient and the patient has been discharged.This was during a procedure to treat a calcified right upper arm fistula in the right brachiocephalic vein which had a central stenosis of 80% and an outflow stenosis of 60%.There was no tortuosity present at the target vessel.The 12mm x 4cm 80cm p3.035 powerflex pta balloon catheter was advanced to the patient¿s central vein and an attempt to inflate the balloon was made.Upon attempted inflation, incomplete balloon filling was observed, and the balloon was deflated and removed easily, remaining in one piece during removal.After removing the powerflex pta balloon catheter, a tiny leak of fluid was observed at the distal balloon tip.There was no difficulty removing the product from the hoop, the protective balloon cover, the stylet, or any of the sterile packaging components.The device maintained negative pressure during preparation and a 40% contrast and 60% saline mixture was used to prep the balloon.There was no resistance or friction experienced as the balloon catheter was being inserted into the patient and the device was never in an acute bend.It was confirmed that the balloon did not fully rupture, there was no evidence of missing pieces, and no evidence of harm to the patient¿s vessel.The device will be returned for evaluation.
Additional Manufacturer Narrative
Complaint conclusion: as reported, there was a leak at the distal balloon tip of a 12mm x 4cm 80cm powerflex p3.035 percutaneous transluminal angioplasty (pta) balloon catheter.As a result, a new 12mm x 4cm 80cm powerflex p3 pta balloon catheter was successfully used.There was no reported injury to the patient and the patient has been discharged.This was during a procedure to treat a calcified right upper arm fistula in the right brachiocephalic vein which had a central stenosis of 80% and an outflow stenosis of 60%.There was no tortuosity present at the target vessel.The 12mm x 4cm 80cm p3.035 powerflex pta balloon catheter was advanced to the patient¿s central vein and an attempt to inflate the balloon was made.Upon attempted inflation, incomplete balloon filling was observed, and the balloon was deflated and removed easily, remaining in one piece during removal.After removing the powerflex pta balloon catheter, a tiny leak of fluid was observed at the distal balloon tip.There was no difficulty removing the product from the hoop, the protective balloon cover, the stylet, or any of the sterile packaging components.The device maintained negative pressure during preparation and a 40% contrast, and 60% saline mixture was used to prep the balloon.There was no resistance or friction experienced as the balloon catheter was being inserted into the patient and the device was never in an acute bend.It was confirmed that the balloon did not fully rupture, there was no evidence of missing pieces, and no evidence of harm to the patient¿s vessel.One product was returned for analysis.A non-sterile powerflex p3 f5 12 x 4 80 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.Per functional analysis, inflation/ deflation test was intent to be performed on the unit.Per dp 12169733 rev 4, 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 balloon of the unit located at the proximal section of the balloon.Per microscopic analysis, sem was performed, results showed that the balloon of the powerflex p3 f5 12x4 80 device presented evidence of a ruptured condition and scratch marks near the damaged area.This type of damage is commonly caused during the interaction of the 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 probably led to the damaged condition found on the received device.It seems the material near the damage was ruptured with a sharp object from the outside of the device.No other anomalies were observed during the sem analysis.A product history record (phr) review of lot 82227796 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.However, the exact cause cannot be determined.During functional analysis, a leakage was noted from the proximal area of the balloon.The outer surface balloon material presented evidence of scratch marks adjacent to the rupture which appears to have been 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.Based on the information available, vessel characteristics and procedural factors likely contributed to the event reported.According to 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 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.¿ 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.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: a review of the manufacturing documentation associated with lot 82227796 presented no issues during the manufacturing process that can be related to the reported event.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.

• Brand Name: POWERFLEX P3 F5 12X4 80
• Common Device Name: 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: 14086031
• Report Number: 9616099-2022-05536
• Device Sequence Number: 13983809
• Product Code: LIT
• UDI-Device Identifier: 20705032003961
• UDI-Public: (01)20705032003961(17)240731(10)82227796
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K032737
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/15/2022

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: 07/31/2024
• Device Model Number: 4202040S
• Device Catalogue Number: 4202040S
• Device Lot Number: 82227796
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2022
• Supplement Date Received by Manufacturer: 04/21/2022; 06/08/2022
• Initial Report FDA Received Date: 04/12/2022
• Supplement Report FDA Received Date: 05/16/2022; 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 12MM X 4CM 80CM POWERFLEX P3 PTA BALLOON CATHETER
• Patient Age: 69 YR
• Patient Sex: Male