MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 8MM4CM 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4400804S
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that an 8x40mm powerflex balloon catheter ruptured at six atmospheres (6 atm).Therefore the balloon catheter was replaced with a new power flex pro (8x20) and inflated at ten (10) atm.The procedure finished successfully.There was no reported patient injury.The target lesion was unknown.The patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was unknown.A 6f brite tip sheath introducer was inserted and a sv guidewire crossed the lesion.Then under ivus (volcano) the lesion was checked and an 8x100 smart stent was deployed in the target lesion.A power flex pro was delivered to the lesion for post dilatation, however it ruptured.The device prep normally.There were no difficulties removing the product from the hoop, the protective balloon cover, the stylet or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product the product into the patient.The product was removed intact (in one piece) from the patient.  the product was not returned for analysis.A device history record (dhr) review of lot 17108228 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 of the burst could not be determined.Based on the limited information available for review, vessel characteristics (although unknown) may have contributed to the reported event as calcification/resistance lesions may cause damage to a balloon.According to the instructions for use, which is not intended as a mitigation, ¿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.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 dhr 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.
Event or Problem Description
It was reported that a power flex balloon catheter ruptured at six atmosphere (6 atm).Therefore the balloon catheter was replaced with a new power flex pro (8*2) and inflated at ten (10) atm.The procedure finished successfully.There was no reported patient injury.A 6f brite tip sheath introducer was inserted and a sv guidewire crossed the lesion.Then under ivus (volcano) the lesion was checked and an 8*10 smart stent was deployed in the target lesion.A power flex pro was delivered to the lesion for post dilatation, however it ruptured.The target lesion was unknown.The patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was unknown.The device prep normally.There were no difficulties removing the product from the hoop, the protective balloon cover, the stylet or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product the product into the patient. the product was removed intact (in one piece) from the patient. the product was clinically used and will not be returned for analysis.

• Brand Name: POWERFLEXPRO 8MM4CM 80
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 6751547
• Report Number: 9616099-2017-01275
• Device Sequence Number: 10968162
• Product Code: LIT
• UDI-Device Identifier: 20705032059814
• UDI-Public: 20705032059814
• 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: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 07/28/2017

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: 08/31/2017
• Device Model Number: 4400804S
• Device Catalogue Number: 4400804S
• Device Lot Number: 17108228
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/04/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2017
• Initial Report FDA Received Date: 07/28/2017
• 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: (6F BRITE TIP SHEATH) GUIDEWIRE (SV WIRE) IVUS