MAUDE Adverse Event Report: CORDIS CASHEL POWERFLEX EXTREME 8X6 80CM; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	4158060S
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/08/2019
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, when the physician attempted to inflate the 8x6 80cm powerflex extreme balloon catheter (bc), it didn¿t fully inflate during initial inflation as the contrast just kept coming out.It happened inside the patient.There was no reported patient injury.The procedure was completed using another cordis balloon.Therefore, the powerflex balloon catheter was removed from the patient, inspected and tossed.The device was stored as per the labeling.The device was prepped per the instructions for use (ifu).The leakage saw under fluoroscopy.The leakage was from the balloon.The device will not be returned for evaluation as it was discarded.
Additional Manufacturer Narrative
After further review of additional information received the following have been updated accordingly.When the physician attempted to inflate the 8 x 6 x 80cm powerflex extreme balloon catheter (bc), it didn¿t fully inflate during initial inflation as the contrast just kept coming out.It happened inside the patient and the leakage from the balloon was noted under fluoroscopy.There was no reported patient injury.The procedure was completed using another cordis balloon.Therefore, the powerflex balloon catheter was removed from the patient, inspected and tossed.The device was stored as per the labeling.The device was prepped per the instructions for use (ifu).The product was not returned for analysis.A product history record (phr) review of lot 82166114 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¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics and procedural factors may have contributed to the reported event.It is likely the catheter encountered a sharp object, for example calcium, which may have damaged/punctured the area.However, without return of the product for analysis it is difficult to draw a clinical conclusion between the device and the reported event.According to the instructions for use, which is not intended as a mitigation of risk, ¿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.Consider the use of systemic heparinization.Flush all devices entering the vascular system with sterile heparinized saline or similar isotonic solution.Flush the ¿thru¿ lumen with sterile heparinized saline or a similar isotonic solution.Carefully advance the catheter through a sheath or through the percutaneous entry site.Note: gentle counterclockwise rotation of the balloon may ease introduction through the sheath or percutaneous entry site.Caution: if strong resistance is met during advancement or withdrawal of the catheter, discontinue movement and determine the cause of resistance before proceeding.If the cause of resistance cannot be determined, withdraw the entire system.¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: POWERFLEX EXTREME 8X6 80CM
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co.; tipperary ; EI
• MDR Report Key: 9291721
• Report Number: 9616099-2019-03341
• Device Sequence Number: 14065617
• Product Code: LIT
• UDI-Device Identifier: 20705032001974
• UDI-Public: 20705032001974
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K032737
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2019

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: 01/31/2022
• Device Catalogue Number: 4158060S
• Device Lot Number: 82166114
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2019
• Supplement Date Received by Manufacturer: 11/09/2019
• Initial Report FDA Received Date: 11/07/2019
• Supplement Report FDA Received Date: 11/15/2019
• 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: - BALLOON CATHETER