MAUDE Adverse Event Report: CORDIS CASHEL POWERFLEX P3 F5 6X8 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4206080S
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record (dhr) review of lot 82156676 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with 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.
Event or Problem Description
As reported, a 5f powerflex p3 6x8 80 percutaneous transluminal angioplasty (pta) balloon catheter (bc) the balloon would not inflate in the patient, after removal from the patient and the wire, it was found that there was a pinhole at the tip of the balloon by using a syringe.There was no reported patient injury.The procedure was completed using a non-cordis balloon.
Additional Manufacturer Narrative
Complaint conclusion: a 5f powerflex p3 6 x 8 x 80 percutaneous transluminal angioplasty (pta) balloon catheter (bc) would not inflate in the patient.The wire and balloon catheter were removed from the patient and it was found that there was a pinhole at the tip of the balloon by using a syringe.There was no reported patient injury.The procedure was completed using a non-cordis balloon.One product was returned for analysis.A non-sterile powerflex p3 f5 6 x 8 x 80 balloon catheter was returned.Per visual analysis, the balloon was coiled inside a plastic bag, no anomalies were observed.Functional test was performed, a syringe filled with water was attached to the inflation lumen and pressure was applied.However, a leakage was observed in the balloon on the proximal section of the balloon area.Sem analysis revealed the balloon leakage was caused by a rupture on the balloon surface.The inner surface of the balloon presented evidence of scratch marks adjacent to the rupture, coming from the outer surface of the balloon.The outer surface presented evidence of bulged/peeled balloon material, scratch marks, tension marks and elongations 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.This would imply the balloon material near the rupture was peeled off with a sharp object from the outside the balloon.No other anomalies were found during the sem analysis.A product history record (phr) review of lot 82156676 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon leakage¿ 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 bulged/peeled balloon material, scratch marks, tension marks and elongations adjacent to the balloon rupture.This type of damage is commonly caused when balloon material encounters a sharp object or mechanical damage.Although unknown, it is likely that vessel characteristics and handling of the device 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 tension marks and elongations 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.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 review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: POWERFLEX P3 F5 6X8 80
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 8799139
• Report Number: 9616099-2019-03082
• Device Sequence Number: 11482314
• Product Code: LIT
• UDI-Device Identifier: 20705032004494
• UDI-Public: 20705032004494
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2019

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: 06/30/2021
• Device Model Number: 4206080S
• Device Catalogue Number: 4206080S
• Device Lot Number: 82156676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019
• Initial Date Received by Manufacturer: 06/19/2019
• Supplement Date Received by Manufacturer: 06/19/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 08/05/2019
• 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: UNKNOWN BALLOON CATHETER; UNKNOWN BALLOON CATHETER