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U.S. Department of Health and Human Services

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

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CORDIS CORPORATION POWERFLEXPRO 6MM22CM 135 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 4400622X
Device Problem Partial Blockage (1065)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/20/2021
Event Type  malfunction  
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 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.
 
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Brand NamePOWERFLEXPRO 6MM22CM 135
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer Contact
karla castro
14201 nw 60 avenue
miami lakes, FL 33014
7863138372
MDR Report Key11338208
MDR Text Key232601088
Report Number9616099-2021-04273
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112797
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number4400622X
Device Catalogue Number4400622X
Device Lot Number82197026
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/22/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/25/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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