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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO 2MM15CM 150 SABER PTA BALLOON CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CARDINAL HEALTH MEXICO 2MM15CM 150 SABER PTA BALLOON CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number N/A
Device Problem Partial Blockage (1065)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/02/2021
Event Type  malfunction  
Manufacturer Narrative
Initial reporter telephone number is (b)(6). As reported, the non-cordis wire could not pass through the cavity of the 2mm x 15cm x 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter. After flushing, there was no heparinized saline outflow at the head-end of the guidewire. The same wire was used with another catheter to complete the procedure. There was no reported patient injury. The non-cordis wire was flushed and/or wiped down prior to attempting to the load the device onto the wire. The wire was in-vitro for 3 minutes before attempting to load the balloon onto the wire. The insertion difficulty was not caused by a blockage of possibly injectable material. The saber was inspected prior to use and appeared to be normal. It was also prepped properly according to the ifu. There was no difficulty reported flushing the catheter prior to use and no problems during prepping. Images are available for review. Previously, a picture evaluation of the images attached to this complaint was performed. Per picture review the complaint reported by the customer as guidewire obstructed could not be confirmed at that time based on the pictures solely information provided. Subsequently, the product was returned for analysis. One non-sterile saber 2mm x 15cm 150 was received for analysis coiled inside a plastic bag. Per visual analysis, no anomalies were observed on the received saber unit. Neither obstructions, nor flattened sections or crystallized contrast medium could be observed at the naked eye. Per functional analysis, a lab sample syringe filled with water was attached to the luer hub of the received catheter with the intent to flush the device. However, flushing could not be achieved. Then, an appropriate. 018¿ steerable lab sample guidewire was intended to be passed along the inner lumen of the unit. Nonetheless, it could not pass through either. Per microscopic analysis, the unit was inspected under the vision system and an obstruction could be seen in the inner body of the unit. The obstruction was located at 89. 8 cm from the hub. A cross-sectional was performed on the unit at the obstructed area. A ripped little piece of nylon from the inner guidewire was found tucked at the affected obstructed area probably cause during the interaction of the saber with a sharp object leading to the ripped little piece of inner guide wire. The id of the guidewire lumen of the unit was measured near to the obstructed area against the specification and the results were found within specification. Infrared spectroscopy was performed, a portion of the complaint saber 2mm x 15cm 150 unit and the ripped small piece of the apparent inner guide wire from the same complaint were delivered to the analytical laboratory for its chemical identification. Infrared spectroscopy was applied to the samples to show both samples chemical composition. The ir spectrum obtained showed that both samples share the characteristic ir absorption bands of the polymer known as polyethylene. This ripped little piece of the analyzed polyethylene from the inner guide wire was found tucked at the affected obstructed area probably cause during the interaction of the saber with a sharp object leading to the ripped little piece of inner guide wire. A product history record (phr) review of lot 82186099 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 confirmed via device analysis as absorption bands of the polymer known as polyethylene was noted obstructing the inner lumen of the device. The exact cause of the reported event could not be determined as the saber passed dimensional analysis. It is likely that procedural techniques and handling of the catheter/guidewire may have contributed to the reported event. During analysis it was noted the material of the obstruction was noted to be absorption bands of the polymer known as polyethylene, it is likely this piece was ripped off during the interaction of the guidewire and inner lumen of the saber. Several factors may have contributed such as inadequate flushing of balloon catheters and/or wiping of guidewires. Interference or friction between devices (including all catheters, wires, sheath introducers, balloon/sds catheters) whether between one or multiple manufacturers product lines is a known common occurrence. Therefore, it is imperative that extreme caution be taken when using these devices in the patient vasculature and proper prepping/flushing of the catheters be performed prior to insertion in the patient. According to the warnings in the safety information in the instructions for use, ¿flush all devices entering the vascular system with sterile heparinized saline or similar isotonic solution. Prior to use, ensure all devices have been flushed and air is removed from the system according to standard medical practice. Failure to do so could result in air entering the vascular system. ¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event. Therefore, no corrective or preventive action will be taken at this time.
 
Event Description
As reported, the non-cordis wire could not pass through the cavity of the 2mm x 15cm x 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter. After flushing, there was no heparinized saline outflow at the head-end of the guidewire. The same wire was used with another catheter to complete the procedure. There was no reported patient injury. Analysis of the returned device indicated a ripped/ torn little piece of nylon from the inner guide wire lumen was found tucked at the affected obstructed area. The non-cordis wire was flushed and/or wiped down prior to attempting to the load the device onto the wire. The wire was in-vitro for 3 minutes before attempting to load the balloon onto the wire. The insertion difficulty was not caused by a blockage of possibly injectable material. The saber was inspected prior to use and appeared to be normal. It was also prepped properly according to the ifu. There was no difficulty reported flushing the catheter prior to use and no problems during prepping. The device will be returned for analysis. Images are available for review.
 
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Brand Name2MM15CM 150 SABER PTA BALLOON CATHETER
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CARDINAL HEALTH MEXICO
av prado sur 150 2d0 piso
ciudad de mexico 11000
MX 11000
Manufacturer (Section G)
CARDINAL HEALTH MEXICO
av prado sur 150 2d0 piso
ciudad de mexico 11000
MX 11000
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key11439171
MDR Text Key245853428
Report Number9616099-2021-04322
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K133843
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number48002015X
Device Lot Number82186099
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/19/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/04/2020
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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