MAUDE Adverse Event Report: CORDIS CORPORATION SABER 5MM30CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 48005030X

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/22/2020

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot (17691860) presented no issues during the manufacturing process that can be related to the reported event.This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Event Description

As reported, cracks in the ¿interface¿ of a 5mm x 30cm 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter were found in preparation for the ¿second balloon filling¿.There was no reported patient injury.The user was trained with the device.The device was opened in the sterile field.The type of damage noted on the device that it was cracked.The device damaged was noted during use.The device was stored and handled per the instructions for use (ifu).There was no damage noted to the package.There were no visible signs of device/package damage prior to use.There were no anomalies noted when the device was taken out of the package.There was no excessive force applied to the device during withdrawal from package.The integrity of the sterile pouch was not compromised.The device was not used in patient.The device will be returned for evaluation.

Manufacturer Narrative

After further review of additional information received the following sections g4, g7, h2, h3 and h6 have been updated accordingly.As reported, cracks in the ¿interface¿ of a 5mm x 30cm 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter were found in preparation for the ¿second balloon filling¿.There was no reported patient injury.The user was trained with the device.The device was opened in the sterile field.The type of damage noted on the device that it was cracked.The device damaged was noted during use.The device was stored and handled per the instructions for use (ifu).There was no damage noted to the package.There were no visible signs of device/package damage prior to use.There were no anomalies noted when the device was taken out of the package.There was no excessive force applied to the device during withdrawal from package.The integrity of the sterile pouch was not compromised.The device was not used in patient.The product was returned for analysis.One non-sterile saber 5mm x 30cm 150 was received for analysis coiled inside a plastic bag.Per visual analysis, the balloon appears to not have been inflated.Blood residues were observed inside the balloon.Also, inflation lumen hub was observed cracked.No other anomalies were observed.Per sem analysis, results revealed the cracked area on hub of the saber presented evidence of plastic deformation and fatigue striations.Plastic deformation and fatigue striations found on the hub material are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the hub material was induced to a tensile force that exceeded the hub material yield strength prior to the separation.No other anomalies were observed during sem analysis.A product history record (phr) review of lot 17691860 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 cracked - during use¿ was confirmed by device analysis.The exact cause cannot be determined.Per device analysis, there was evidence of plastic deformation and fatigue striations noted on the hub of the balloon catheter.It appears the hub material was induced to a tensile force that exceeded the material yield strength prior to the separation/crack.Overtightening has been known to cause cracks in luer hubs, it is likely that this type of rough handling was a contributing factor.It is important to proceed with caution during device preparation when attaching the inflation lumen to the balloon catheter.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.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.¿ 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 5MM30CM 150
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 10296116
• MDR Text Key: 199684624
• Report Number: 9616099-2020-03792
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032069578
• UDI-Public: 20705032069578
• Combination Product (y/n): N
• PMA/PMN Number: K971010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: 48005030X
• Device Catalogue Number: 48005030X
• Device Lot Number: 17691860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2020
• Date Manufacturer Received: 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1