MAUDE Adverse Event Report: CORDIS DE MEXICO POWERFLEX P3 F5 12X4 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 4202040S

Device Problems Burst Container or Vessel (1074); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/04/2017

Event Type  malfunction  

Manufacturer Narrative

Manufacturing record (dhr) review was conducted and the product met quality requirements for product acceptance per the applicable manufacturing quality plan.  the product was returned for evaluation and testing; however, the engineering evaluation is not complete.Additional information will be submitted within 30 days upon receipt.

Event Description

As reported, the 80cm.5 fr.Powerflex p3 12 x 4 balloon catheter (bc) ruptured at below the rated burst pressure (rbp) creating a circumferential tear in the balloon.There was no reported patient injury.The product will be returned for inspection.Additional information received indicated that the target lesion was the basilica vein of the mid arm.The balloon burst occurred at between approximately eight to ten atmospheres (8-10 atm.).The approach was from the left upper arm fistula.A non-cordis balloon catheter was used to complete the procedure successfully without patient injury.The balloon catheter (complaint product) was removed intact from the patient.There was no other product issue noted either at the account after the procedure or prior to shipping for inspection.There was no difficulty removing the product from the hoop.There was no difficulty removing the protective balloon cover, 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 prepped normally (i.E.Maintained negative pressure).Non-cordis contrast was used for the procedure.The ratio of contrast to saline was twenty-five percent (25%) contrast to seventy-five percent (75%) saline.A non-cordis inflation device was used for the procedure and was used subsequently with other devices.There was no reported resistance/friction while inserting the balloon through the rotating hemostatic valve.There was no reported resistance/friction while inserting the balloon through the guide catheter.There was no reported difficulty advancing the balloon catheter through the vessel or difficulty crossing the lesion.The catheter was not ever in an acute bend.The balloon catheter did not kink while being used.There was some difficulty reported removing the ruptured product from the patient after the reported product issue.Addendum: the product was returned for inspection and the preliminary comments indicated that the device was received with an unknown sheath attached and the balloon ruptured/in two pieces.Additional information received indicated that the balloon separation occurred in the patient and was noted upon removal of the device from the patient. no additional information is available.

Manufacturer Narrative

Additional information received indicated that the sheath used for the procedure was a 7 fr.Cordis sheath.There were no reported product issues with the sheath used.    the 80 cm.5 fr.Powerflex p3 12 x 4 balloon catheter (bc) ruptured at below the rated burst pressure (rbp) creating a circumferential tear in the balloon.There was no reported patient injury.The target lesion was the basilica vein of the mid arm.The balloon burst occurred at between approximately eight to ten atmospheres (8-10 atm.).The approach was from the left upper arm fistula.A non-cordis balloon catheter was used to complete the procedure successfully without patient injury.The balloon catheter was removed intact from the patient.There was no other product issue noted either at the account after the procedure or prior to shipping for inspection.There was no difficulty removing the product from the hoop.There was no difficulty removing the protective balloon cover, 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 prepped normally (i.E.Maintained negative pressure).Non-cordis contrast was used for the procedure.The ratio of contrast to saline was twenty-five percent (25%) contrast to seventy-five percent (75%) saline.A non-cordis inflation device was used for the procedure and was used subsequently with other devices.There was no reported resistance/friction while inserting the balloon through the rotating hemostatic valve.There was no reported resistance/friction while inserting the balloon through the guide catheter.There was no reported difficulty advancing the balloon catheter through the vessel or difficulty crossing the lesion.The catheter was not ever in an acute bend.The balloon catheter did not kink while being used.There was some difficulty reported removing the ruptured product from the patient after the reported product issue.Addendum: the product was returned for inspection and the preliminary comments indicated that the device was received with an unknown sheath attached and the balloon ruptured/in two pieces.Additional information received indicated that the balloon separation occurred in the patient and was noted upon removal of the device from the patient.The sheath used was a 7 fr.Cordis sheath.There were no reported product issues with the sheath used.  a non-sterile unit of powerflex p3 f5 12x4 80 was received inside of a plastic bag.Catheter was received inside of a 7 fr cannula sheath introducer.Balloon was observed already separated 3 cm from proximal section and 2 cm from distal section.Functional analysis could not be performed due to balloon already separated.Id of guide wire lumen was measured using a 0.035¿ guide wire lab sample and it was able to advance without difficulty.Device was inspected under vision system and brite tip of csi was observed bent and wrinkled.Sem analysis results showed that the internal did not presented any evidence of damages.However, the external surface presented evidence of scratch marks near to the balloon burst/ separated areas and it¿s very likely that the same factors could have contributed to the burst/separated condition found on the received balloon.No other anomalies were observed during sem analysis.A device history record (dhr) review of lot 17521814 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.  the failure reported by the customer as ¿balloon/ burst - at/below rbp¿ and ¿balloon/ separated - in-patient¿ were confirmed due to product received condition.The cause of the event experienced by the customer could not be conclusively determined.Based on information provided, vessel characteristics (although unknown) may have contributed to the burst reported as evidenced by the scratch marks noted during analysis.Procedural factors might have contributed to the separation.According to the instructions for use ¿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.¿ also noted in the ifu, ¿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 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.

• Brand Name: POWERFLEX P3 F5 12X4 80
• 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 ave.; miami lakes, FL 33014
• MDR Report Key: 6289236
• MDR Text Key: 66138678
• Report Number: 9616099-2017-00885
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032737
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: 4202040S
• Device Catalogue Number: 4202040S
• Device Lot Number: 17521814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2017
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/04/2017
• Date Manufacturer Received: 01/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2016
• 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