MAUDE Adverse Event Report: CORDIS DE MEXICO POWERFLEXPRO 5MM15CM 135; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 4400515X

Device Problems Material Frayed (1262); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/11/2017

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 is available for evaluation and testing.However, the product has not been returned as of to date.Additional information will be submitted within 30 days upon receipt.

Event Description

As reported, during an interventional procedure, while attempting to pot-dilate a smart 6 mm.Stent, the 135 cm.Powerflexpro 5 mm.X 15 cm.Balloon catheter became stuck on the stent during advancement.The product was successfully removed from the patient.Upon inspection after removal, the distal tip was noted to be frayed.The procedure completed successfully although the details were unknown.There was no reported patient injury.The product was clinically used and it will be returned for analysis.The target lesion was unknown.No target lesion characteristic information was available.

Manufacturer Narrative

Additional information received indicated that the product will not be returned for inspection.Event description updated.  during an interventional procedure, while attempting to post-dilate a smart 6 mm.Stent, the 135 cm.Powerflex pro 5 mm.X 15 cm.Balloon catheter became stuck on the stent during advancement.The product was successfully removed from the patient.Upon inspection after removal, the distal tip was noted to be frayed.The procedure completed successfully although the details were unknown.There was no reported patient injury.The target lesion was unknown.No target lesion characteristic information was not available.Additional information received indicated that the powerflex pro (complaint product) was removed intact from the patient.The product was stored properly according to the instructions for use (ifu).There was no damage noted to the product packaging upon inspection prior to use.There was no reported difficulty removing the product from the packaging.The product was inspected prior to use and appeared to be normal.The product was prepped properly according to the ifu.Additional information was requested but was reported to be unknown.No additional information is available.The product was not returned for analysis.A device history record (dhr) review of lot 17417368 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿pta/ptca system tracking difficulty - through stent¿ and ¿distal tip frayed/split/torn - in-patient¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Procedural factors may have contributed to the reported event as the event description states the ¿balloon catheter became stuck on the stent during advancement¿.According to 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 dhr nor the limited 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 Description

As reported, during an interventional procedure, while attempting to pot-dilate a smart 6 mm.Stent, the 135 cm.Powerflexpro 5 mm.X 15 cm.Balloon catheter became stuck on the stent during advancement.The product was successfully removed from the patient.Upon inspection after removal, the distal tip was noted to be frayed.The procedure completed successfully although the details were unknown.There was no reported patient injury.The product was clinically used and it will not be returned for analysis.The target lesion was unknown.No target lesion characteristic information was available.Additional information received indicated that the powerflexpro (complaint product) was removed intact from the patient.The product was stored properly according to the instructions for use (ifu).There was no damage noted to the product packaging upon inspection prior to use.There was no reported difficulty removing the product from the packaging.The product was inspected prior to use and appeared to be normal.The product was prepped properly according to the ifu.Additional information was requested but was reported to be unknown.No additional information is available.

• Brand Name: POWERFLEXPRO 5MM15CM 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 ave.; miami lakes, FL 33014
• MDR Report Key: 6298204
• MDR Text Key: 66445379
• Report Number: 9616099-2017-00890
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112797
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2017
• 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: 4400515X
• Device Catalogue Number: 4400515X
• Device Lot Number: 17417368
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/12/2017
• Date Manufacturer Received: 02/16/2017
• Date Device Manufactured: 03/01/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SMART 6 MM. STENT