MAUDE Adverse Event Report: CORDIS CASHEL SABER 5MM4CM 90; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number 48005004S

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/26/2019

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot (17718393) presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, a saber pta balloon catheter (5mm4cm 90) was used for inflation.The wire lumen could be flushed without any issues.However, a thread like nylon about 1-centimeter (cm) came out when a guide wire was inserted.There was no reported patient injury.Therefore, a wire was removed and inserted after the flush.The procedure was completed.The lesion was the superficial femoral artery.Initially, the wire was used with another non-cordis balloon catheter before the saber pta balloon catheter was used.There was no evidence of anything attached to the wire.The product will not be returned for analysis as the device was discarded but the things like thread will be returned.

Manufacturer Narrative

A saber percutaneous transluminal angioplasty (pta) balloon catheter (5mm x 4cm x 90cm) was used for inflation.The wire lumen could be flushed without any issues.However, a thread like nylon about 1-centimeter (cm) came out when a guide wire was inserted.There was no reported patient injury.Therefore, a wire was removed and inserted after the flush.The procedure was completed.The lesion was the superficial femoral artery.Initially, the wire was used with another non-cordis balloon catheter before the saber pta balloon catheter was used.There was no evidence of anything attached to the wire.The product will not be returned for analysis as the device was discarded but the thread will be returned.One non-sterile plastic tube was received for analysis inside a plastic bag.Per visual analysis, a thread of material was noted inside the tube.The material is approximately 1 cm long.Infrared spectroscopy was applied, the foreign material found on a saber guide-wire lumen is composed of a polyethylene plastic.A product history record (phr) review of lot 17718393 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿pta/ptca system - foreign material¿ could not be confirmed.The exact cause of the reported event could not be determined.It cannot be assumed that the material returned for analysis was found inside the guidewire lumen of the catheter without any evidence, procedural films or photos.The material was analyzed with ftir, the foreign material returned is composed of a polyethylene (pe) plastic.This is not the material composition of a saber balloon catheter.It is likely that procedural techniques and handling of the catheter may have contributed to the reported event.According to the warnings in the safety information in the instructions for use ¿prior to angioplasty, the catheter should be examined to verify functionality and integrity, and ensure that its size and shape are suitable for the specific procedure for which it is to be used.Do not use if product damage is suspected or evident.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.

• Brand Name: SABER 5MM4CM 90
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co.; tipperary ; EI
• MDR Report Key: 8927702
• MDR Text Key: 197111439
• Report Number: 9616099-2019-03161
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032068649
• UDI-Public: 20705032068649
• Combination Product (y/n): N
• PMA/PMN Number: K971010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2019
• 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 Catalogue Number: 48005004S
• Device Lot Number: 17718393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2019
• Date Manufacturer Received: 08/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1