MAUDE Adverse Event Report: CORDIS DE MEXICO POWERFLEXPRO 8MM6CM 135; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 4400806X

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/03/2017

Event Type  malfunction  

Manufacturer Narrative

As reported, the powerflex pro 8mm 6cm 135 balloon was inserted into body-vessel-position.During inflation, physician noticed air on proximal end of balloon where the balloon was not inflating and getting to nominal pressure.It was later noted during evaluation of the device; the balloon device had a 3cm axial burst observed at the distal section of the balloon.The balloon catheter was easily removed.The physician used the balloon for pre-dilation of an external artery where it was mildly calcified.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 device prep normally.The contrast to saline ratio was 1:1.There was no difficulty crossing the lesion.The catheter has never been in an acute bend.The device was not used for a chronic total occlusion.The balloon catheter did not kink while being used.There was no resistance/friction with other devices.The following information was unknown: contrast media used; type and brand of inflation device used; indeflator used successfully with other devices; resistance/friction while inserting the balloon through the rotating hemostatic valve, the guide catheter, or the vessel; and the target lesion.One non-sterile unit of powerflexpro 8mm6cm 135 was received coiled inside a plastic bag.Per visual analysis, it was noticed that the balloon was previously inflated and deflated.No anomalies or damages were found on the received device.Leak test was performed to the received unit, the balloon device was inflated and 3cm axial burst was observed at the distal section of the balloon.Unit was sent to sem analysis and results showed that the external surface presented evidence of scratch marks near to the balloon burst and it¿s very likely that the same factors that caused the scratch marks on the balloon outer surface also contributed to the burst condition.The internal surface and distal marker band did not present any evidence of damages.No other anomalies were found during the analysis.A device history record (dhr) review of lot 17558986 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.  the reported ¿balloon - inflation difficulty¿ was confirmed during product analysis since a burst condition was found on the balloon.The cause of the balloon burst could not be conclusively determined during the analysis.Based on the limited information provided, vessel characteristics (mild calcification) may have contributed to the reported event as evidenced by the scratch marks noted during sem analysis.According to the instructions for use (ifu), ¿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.¿ neither the dhr 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.

Event Description

Additional information was received and during the evaluation of the device; the balloon device was inflated and 3cm axial burst was observed at the distal section of the balloon.As reported, the power flex pro 8mm 6cm 135 balloon was inserted into body-vessel-position.During inflation, physician noticed air on proximal end of balloon where the balloon was not inflating and getting to nominal pressure.Used balloon for pre-dilation of external artery where it was mildly calcified.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 device prep normally.The contrast to saline ratio was 1:1.There was no difficulty crossing the lesion.The catheter has never been in an acute bend.The device was not used for a chronic total occlusion.The balloon catheter did not kink while being used.There was no resistance/friction with other devices.The balloon catheter was easily removed.The following information was unknown: contrast media used; type and brand of inflation device used; indeflator used successfully with other devices; resistance/friction while inserting the balloon through the rotating hemostatic valve, the guide catheter, or the vessel; and the target lesion.

• Brand Name: POWERFLEXPRO 8MM6CM 135
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer (Section G): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer Contact: cecil navajas ; 14201 nw 60th avenue; miami, FL 33014
• MDR Report Key: 6513466
• MDR Text Key: 73460905
• Report Number: 9616099-2017-01051
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032059845
• UDI-Public: 20705032059845
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: 4400806X
• Device Catalogue Number: 4400806X
• Device Lot Number: 17558986
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2017
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/01/2017
• Date Manufacturer Received: 04/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1