MAUDE Adverse Event Report: CORDIS CASHEL POWERFLEX EXTREME 7X4 80CM; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 4157040S

Device Problems Burst Container or Vessel (1074); Detachment Of Device Component (1104); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/06/2017

Event Type  Injury  

Manufacturer Narrative

Complaint conclusion: as reported, a power flex extreme (7 x 4 80 cm) percutaneous transluminal angioplasty (pta) balloon catheter was delivered to the lesion and inflated, but it ruptured horizontally.The physician attempted to remove the power flex extreme, however it could not be removed.The physician attempted to remove it with a concomitant sheath, but it could not be removed.Therefore, a surgical operation was performed to remove the power flex extreme.The product was not removed intact (in one piece) from the patient.The procedure completed successfully.There was no reported patient injury.The device was stored and handled per the instructions for use (ifu).There was no difficulty in removing the stylet or any of the sterile packaging components.There was no difficulty in removing the product from the hoop.There was no difficulty in removing the protective balloon cover.The device was prepped per the ifu.The device was prepped normally (i.E.Maintained negative pressure).The product was clinically used.The lesion was at an anastomotic part of an artificial vessel and the vein.The diameter of the lesion was small.The patient¿s information was unknown.The target lesion was the shunt.The patient¿s vessel level of tortuousness and calcification was unknown.There was severe stenosis at the anastomotic part.There were no anomalies on the complaint device prior to use.The non-sterile distal part of a powerflex extreme 7 x 4 80 cm was received inside a plastic bag.The powerflex was received inserted in a non-cordis sheath introducer, a distal section of the sheath introducer was cut and missing; it was also observed that a non cordis guide wire was inserted in the received powerflex.Radial ruptures were observed at 0.7 cm proximally of the distal end of the balloon and at 1.4 cm distally from the proximal end of the balloon, the middle section of the balloon was missing and it was not received.Withdrawal test was attempted to be performed on the received pta unit, however because of the balloon rupture condition, it was not possible.The unit was sent to sem analysis in order to find the potential cause of the balloon rupture/separation and sem results showed that the external surface of balloon presented evidence of scratches, abrasion marks and splits near to the balloon rupture.It¿s very likely that the same factors that caused these damages on the balloon¿s outer surface could have also contributed to the burst/ rupture found on the received balloon.A device history record (dhr) review of lot 17431054 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon ¿ burst¿ and ¿pta/ptca system - withdrawal difficulty¿ was confirmed through analysis of the device.However, the exact cause of the events experienced could not be determined during analysis.Based on the limited information available for review, vessel characteristics (severe stenosis of small diameter artificial vessel) and procedural factors may have contributed to the balloon rupture as evidenced by the scratches and abrasions on the balloons surface during sem analysis.Procedural/handling factors likely contributed to the withdrawal difficulty and separation noted during analysis as evidenced by the splits near the balloon rupture since this damage may have impeded the withdrawal of the powerflex from the sheath.As warned in the instructions for use, which is not intended as a mitigation, ¿do not advance or retract the catheter unless the balloon is fully deflated under vacuum.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.¿ as cautioned by the ifu, ¿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.Caution: 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.Note: gentle counterclockwise rotation of the balloon may ease withdrawal from the sheath or from the percutaneous entry site.If the balloon cannot be withdrawn through the sheath, withdraw the catheter and sheath as a unit.¿ neither the dhr review nor the product analysis suggests that the event experienced by the customer could be related to the design or manufacturing process of the product.Therefore, no corrective/preventive action will be taken at this time.

Event Description

As reported, a power flex extreme (7 x 4 80 cm) percutaneous transluminal angioplasty (pta) balloon catheter was delivered to the lesion and inflated, but it ruptured horizontally.The physician attempted to remove the power flex extreme, however it could not be removed.The physician attempted to remove it with a concomitant sheath, but it could not be removed.Therefore, a surgical operation was performed to remove the power flex extreme.The product was not removed intact (in one piece) from the patient.The procedure completed successfully.There was no reported patient injury.The device was stored and handled per the instructions for use (ifu).There was no difficulty in removing the stylet or any of the sterile packaging components.There was no difficulty in removing the product from the hoop.There was no difficulty in removing the protective balloon cover.The device was prepped per the ifu.The device was prepped normally (i.E.Maintained negative pressure).The product was clinically used and will be returned for analysis.The lesion was at an anastomotic part of an artificial vessel and the vein.The diameter of the lesion was small.The patient¿s information was unknown.The target lesion was the shunt.The patient¿s vessel level of tortuousness and calcification was unknown.There was severe stenosis at the anastomotic part.There were no anomalies on the complaint device prior to use.

• Brand Name: POWERFLEX EXTREME 7X4 80CM
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel; co. tipperary ; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel; co. tipperary ; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6763464
• MDR Text Key: 81705233
• Report Number: 9616099-2017-01288
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K032737
• 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: 08/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: 4157040S
• Device Catalogue Number: 4157040S
• Device Lot Number: 17431054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2016
• 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
• Patient Outcome(s): Required Intervention