MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 4MM4CM 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4400404S
Medical Device Problem Codes	Material Frayed (1262); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information to include from facility name: (b)(6) hospital.Phone number: (b)(6).The product was not returned for analysis.Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
During use, the powerflex pro balloon catheter was delivered to the lesion and upon inflation there was a confirmed the leakage of the contrast media.When the device was removed, a "split" in the device was noticed.There was no patient injury.Therefore the powerflex balloon was removed and replaced with a new unknown balloon catheter and the procedure was completed.The lesion was the superficial femoral artery which had severe calcification.The physician commented that this issue might have occurred by severe calcification.The device was discarded by mistake.
Additional Manufacturer Narrative
Additional information was received and the expiration and manufacturing date was updated.
Additional Manufacturer Narrative
During use, the powerflex pro balloon catheter was delivered to the lesion and upon inflation there was a confirmed leakage of the contrast media.When the device was removed, a "split" in the device was noticed.There was no patient injury.Therefore, the powerflex balloon was removed and replaced with a new unknown balloon catheter and the procedure was completed.The lesion was the superficial femoral artery which had severe calcification.The physician commented that this issue might have occurred due to severe calcification.The device was not returned for analysis.A product history record (phr) review of lot 82148149 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¿ and ¿balloon frayed/split/torn-in-patient¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics of severe calcification may have contributed to the reported event, as calcification is known to cause damage to balloon material.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 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.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.¿ 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: POWERFLEXPRO 4MM4CM 80
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 8456897
• Report Number: 9616099-2019-02809
• Device Sequence Number: 429838
• Product Code: LIT
• UDI-Device Identifier: 20705032059142
• UDI-Public: 20705032059142
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112797
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/15/2019

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: 10/31/2020
• Device Model Number: 4400404S
• Device Catalogue Number: 4400404S
• Device Lot Number: 82148149
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/27/2019
• Supplement Date Received by Manufacturer: 04/02/2019; 04/04/2019
• Initial Report FDA Received Date: 03/27/2019
• Supplement Report FDA Received Date: 04/04/2019; 04/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1