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

Model Number 48002020X

Device Problem Partial Blockage (1065)

Patient Problem No Consequences Or Impact To Patient (2199)

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.

• Brand Name: SABER 2MM20CM 150
• Type of Device: CATHETER, 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 Key: 8781451
• MDR Text Key: 150731761
• Report Number: 9616099-2019-03069
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032069219
• UDI-Public: 20705032069219
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K971010
• Number of Events Reported: 1
• 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: 07/11/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: 48002020X
• Device Catalogue Number: 48002020X
• Device Lot Number: 17717472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/01/2019
• Initial Date FDA Received: 07/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1