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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL SABER 2MM20CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CASHEL SABER 2MM20CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 48002020X
Device Problems Partial Blockage; Catheter
Event Date 05/04/2019
Event Type  Malfunction  
Manufacturer Narrative

Complaint conclusion: the guide wire could not pass through the saber (2mm x 20cm 150cm) balloon catheter (bc), and the balloon could not be used. There was no reported patient injury. A non-cordis guidewire was used. There were no anomalies noted during the prep of the device. There was no damage noted to the box, pouch, hoop or balloon sleeve. There was no difficulty removing the balloon sleeve. There were no kinks noted on the device prior to use. The access site had calcification but no scarring. The device was not inserted into the patient. There were no kinks noted on the device during or after use. Force was never required when using the device. The device was not obstructed with particles that could have been injected into the patient. Another balloon was used to complete the procedure. The same guidewire was successfully used with another device. The product was returned for analysis. A non-sterile saber 2mm x 20cm 150cm bc was received coiled inside a plastic bag. A guide wire sample was received inserted though the catheter. Per visual analysis no damages or anomalies were noted. Per functional analysis a 0. 018¿ emerald guidewire (lab sample) was inserted through the guidewire lumen. An obstruction was noted inside the guidewire lumen, therefore a cross-section analysis was performed on the obstructed area. Per cross-section analysis, the obstructed area noted on the guidewire lumen was sectioned and a foreign material was found blocking the lumen. Foreign material was retrieved for a ftir analysis to determine its composition. Also, red blood-like stains were observed on tip of foreign material. Per infrared spectroscopy (ftir analysis) the foreign material is composed of a polyethylene (pe) plastic. Pe is widely used in manufacturing packaging materials; including plastic bags, films and bottles. In addition, based on kastle-meyer analysis it is conclude that red stains on sample received are blood. A product history record (phr) review of lot 17717472 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 ¿ during prep¿ was confirmed through analysis of the returned device. The exact cause of the event could not be determined during analysis. Based on the information available for review, procedural factors may have contributed to the event as evidenced by ftir analysis results showing that the foreign material found inside guidewire lumen is composed of a polyethylene (pe) plastic. Pe is widely used in manufacturing packaging materials; including plastic bags, films and bottles. Pe is not known to be a component of the saber bc therefore this must have originated from another source. A likely scenario is the material was introduced into the guidewire lumen by contaminated saline flush when flushing the device. According to 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. Flush the ¿thru¿ lumen with sterile heparinized saline or a similar isotonic solution. ¿ 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/preventive action will be taken at this time.

 
Event Description

As reported, the guide wire could not pass through the saber (2mm20cm 150) balloon, and the balloon could not be used. There was no reported patient injury. The product will be returned for analysis. A non-cordis guidewire was used. There were no anomalies noted during the prep of the device. There was no damage noted to the box, pouch, hoop or balloon sleeve. There was no difficulty removing the balloon sleeve. There were no kinks noted on the device prior to use. The access site had calcification but no scarring. The device was not inserted into the patient. There were no kinks noted on the device during or after use. Force was never required when using the device. The device was not obstructed with particles that could have been injected into the patient. Another balloon was used to complete the procedure. The same guidewire was successfully used with another device. Per fal analysis, an obstruction was observed inside the guidewire lumen; therefore, a cross-section analysis was performed on the obstructed area. Per cross-section analysis, the obstructed area observed on the guidewire lumen was sectioned and a foreign material was found blocking the lumen.

 
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Brand NameSABER 2MM20CM 150
Type of DeviceCATHETER, 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
7863138372
MDR Report Key8781451
Report Number9616099-2019-03069
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 07/11/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/11/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number48002020X
Device Catalogue Number48002020X
Device LOT Number17717472
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/13/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/01/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/21/2017
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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