MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 9MM2CM 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4400902S
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information to include from 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 rupture at eight atmosphere (8 atm).There was no patient injury.The powerflex pro was removed and a new competitor's bc was used to complete the procedure.The target lesion was the left common iliac artery which has severe calcification and high rate stenosis.An ipsilateral approach was made with a 6f competitor's guiding sheath.A competitor's guidewire was inserted and crossed the lesion and ivus was used to checked the lesion.A powerflex pro bc was inserted and an attempted was made to inflated at 8 atm.However it ruptured during its initial inflation.Therefore balloon was replaced with a new competitor's balloon catheter and it inflated.After that a new powerflex pro inflated and the procedure was completed.The device was discarded in the hospital.
Additional Manufacturer Narrative
During use, the powerflex pro balloon catheter (bc) was inserted, and an attempt was made to inflate to eight atmospheres (8 atm).There was no patient injury.The powerflex pro was removed, and a new competitor's bc was used to complete the procedure.The target lesion was the left common iliac artery which had severe calcification and a high rate of stenosis.An ipsilateral approach was made with a 6f competitor's guiding sheath.A competitor's guidewire was inserted and crossed the lesion and intravascular ultrasound (ivus) was used to check the lesion.A powerflex pro bc at 8 atm.However, it ruptured during its initial inflation.The product was not returned for analysis.A product history record (phr) review of lot 82148912 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst-at/below rbp¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics of severe calcification and a high rate of stenosis may have contributed to the reported event.Damage to balloon material may occur when attempting to cross a severely stenosed vessel that is calcified.However, without the return of the device for analysis, it is difficult to draw a clinical conclusion between the device and the event reported.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 or preventive action will be taken at this time.

• Brand Name: POWERFLEXPRO 9MM2CM 80
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 8896321
• Report Number: 9616099-2019-03149
• Device Sequence Number: 11115987
• Product Code: LIT
• UDI-Device Identifier: 20705032059890
• UDI-Public: 20705032059890
• 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
• Report Date (Section B): 09/05/2019

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: 11/30/2020
• Device Model Number: 4400902S
• Device Catalogue Number: 4400902S
• Device Lot Number: 82148912
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/18/2019
• Supplement Date Received by Manufacturer: 08/16/2019
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 09/05/2019
• 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: BALLOON CATHETER (6MM*4CM ANGIOSCUPT); GUIDEWIRE (TREASURE FLOPPY, ASAHI INTECC); GUIDING SHEATH (6F 25CM, TERUMO); BALLOON CATHETER (6MM*4CM ANGIOSCUPT); GUIDEWIRE (TREASURE FLOPPY, ASAHI INTECC); GUIDING SHEATH (6F 25CM, TERUMO)