MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 6MM22CM 135; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4400622X
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint conclusion: as reported, a 6mm x 22cm x 135cm power flex pro percutaneous transluminal angioplasty (pta) balloon catheter failed to advance over a.035¿ non-cordis hydrophilic wire.Upon wetting the wire with a wet 4 x 4, attempts to advance the power flex pro pta balloon over the wire were met with significant resistance to the point the physician gave up.It was noted that it was possible the difficulty was caused by a blockage of possibly injectable material, but the user was unable to tell.The physician used a non-cordis device to complete the procedure.There was no reported patient injury.The device was stored and prepped as per the instruction for use (ifu).The intended procedure was a pta of sfa following atherectomy.There was no difficulty experienced in prepping the device.A contralateral approach was used.The device did not kink nor bend at any time prior to the resistance/friction.The other devices used with the product did not kink nor bend at any time.The product, nor any of the other devices used with it, had not been resterilized.The product was not returned for analysis.A product history record (phr) review of lot 82197026 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿guidewire lumen- obstructed¿ was not confirmed as the device was not returned for analysis.The exact cause could not be determined.It is likely procedural factors and handling of the device may have contributed to the event reported by the customer.Use of the device with the concomitant hydrophilic wire may also be a contributing factor.However, without the return of the device for analysis or concomitant wire used with the device, it is difficult to draw a clinical conclusion between the device and the event reported.According to the safety information in the instructions for use ¿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.Flush the ¿thru¿ lumen with sterile heparinized saline or a similar isotonic solution.Place the prepared catheter over a prepositioned guidewire and advance the tip to the introduction site.If resistance is met during manipulation, determine the cause of the resistance before proceeding.Consider the use of systemic heparinization.Flush all devices entering the vascular system with sterile heparinized saline or similar isotonic solution.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 phr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process.Therefore, no corrective or preventive action will be taken at this time.
Event or Problem Description
As reported, a 6mm x 22cm x 135cm power flex pro percutaneous transluminal angioplasty (pta) balloon catheter failed to advance over a.035¿ non-cordis hydrophilic wire.Upon wetting the wire with a wet 4 x 4, attempts to advance the power flex pro pta balloon over the wire were met with significant resistance to the point the physician gave up.It was noted that it was possible the difficulty was caused by a blockage of possibly injectable material, but the user was unable to tell.The physician used a non-cordis device to complete the procedure.There was no reported patient injury.The device was stored and prepped as per the instruction for use (ifu).The intended procedure was a pta of sfa following atherectomy.There was no difficulty experienced in prepping the device.A contralateral approach was used.The device did not kink nor bend at any time prior to the resistance/friction.The other devices used with the product did not kink nor bend at any time.The product, nor any of the other devices used with it, had not been resterilized.The device will not be returned for evaluation.

• Brand Name: POWERFLEXPRO 6MM22CM 135
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 11338208
• Report Number: 9616099-2021-04273
• Device Sequence Number: 792804
• Product Code: LIT
• UDI-Device Identifier: 20705032059647
• UDI-Public: 20705032059647
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K112797
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/17/2021

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: 06/30/2023
• Device Model Number: 4400622X
• Device Catalogue Number: 4400622X
• Device Lot Number: 82197026
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2021
• Initial Report FDA Received Date: 02/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1