MAUDE Adverse Event Report: CORDIS CASHEL SABER 2MM15CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	48002015X
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The shaft of the saber 2mm x 15cm x 150cm was broken during the procedure.The target lesion was the superficial femoral artery (sfa).There were no reported patient injuries.The device was stored, handled and prepped normally, by maintaining negative pressure per the instructions for use (ifu).There were no anomalies noted to the device when it was taken out of the packaging.There was no difficulty removing the product from the packaging, removing the product from the hoop or removing the protective balloon cover.There were no kinks or other damages noted prior to inserting the product into the patient.There was no kinks/bends in the device.The saber was removed, and another balloon was used to complete the procedure.One product was returned for analysis.One non-sterile saber 2mm x 15cm x 150cm was returned for analysis.Per visual analysis, the balloon catheter was received coiled inside a plastic bag.The body/shaft is separated, the edges on the separation appear to be elongated.No original packaging was returned.No other anomalies were observed.Per microscopic analysis, elongations were observed along the edges of the separation of the body/shaft.Elongations are commonly associated with ruptures caused by material stretching force overload.Therefore, it is thought that the body/shaft was induced to a tensile force that exceeded the material yield strength prior to the separation.A product history record (phr) review of lot 17548911 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿body/shaft - separated in patient¿ was confirmed through analysis of the returned device.However, the exact cause of the separation could not be determined.During analysis, elongations were observed along the edges of the separated body.These elongations are commonly associated with ruptures caused by material stretching force overload.Therefore, the body/shaft was induced to a tensile force that exceeded the material yield strength.It is likely that procedural factors and handling of the catheter contributed to this separation.According to the safety information of the instructions for use ¿if resistance is felt upon removal, then the balloon, guidewire and the sheath should be removed together as a unit, particularly if balloon rupture or leakage is known or suspected.Proper functioning of the catheter depends on its integrity.Care should be used when handling the catheter.Damage may result from kinking, stretching, or forceful wiping of the catheter.Forceful handling can result in catheter separation and the subsequent need to use a snare or other medical interventional techniques to retrieve the pieces.Always verify integrity of the catheter after removal.¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.
Event or Problem Description
As reported, the shaft of the saber 2mm15cm 150 was broken during the procedure.There were no reported patient injuries.Additional information observed from the product analysis states that the body/shaft of the device was separated, and the edges of the separation looks elongated.The device was stored, handled and prepped per the instructions for use (ifu).The device was prepped normally by maintaining negative pressure.There were no anomalies noted to the device when it was taken out of the packaging.There was no difficulty removing the product from the packaging or removing the product from the hoop.There was no difficulty removing the protective balloon cover.There were no kinks or other damages noted prior to inserting the product into the patient.The body/shaft was separated.There was no kinks/bends in the device.The target lesion was the superficial femoral artery (sfa).The saber was removed and another balloon was used to complete the procedure.Additional procedural details were requested but are unknown.

• Brand Name: SABER 2MM15CM 150
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 8802018
• Report Number: 9616099-2019-03085
• Device Sequence Number: 13567314
• Product Code: LIT
• UDI-Device Identifier: 20705032069202
• UDI-Public: 20705032069202
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K971010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/18/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 48002015X
• Device Lot Number: 17548911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/03/2019
• Initial Report FDA Received Date: 07/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1