MAUDE Adverse Event Report: CORDIS CASHEL SABER 2.5MM4CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 48002504X

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/20/2017

Event Type  malfunction  

Manufacturer Narrative

Complaint conclusion: as reported, during prep, the 2.5x40mm 150cm saber balloon catheter (bc) became stuck to the guidewire and detached from the device.The resistance was felt while advancing the balloon on the wire, the physician attempted to retracted the device in order to wipe the wire for more lubricity; however, at that moment a part of the balloon detached on the table.There was no reported patient injury.The product was stored, handled, inspected and prepped according to the ifu.There was no difficulty experienced when removing the device from its packaging.There was no difficulty in removing the stylet or any of the sterile packaging components, the product from the hoop, or the protective balloon cover.The device looked normal when taken from its packaging.There were kinks or other damages noted while advancing balloon on wire.The same indeflator was used successfully with other devices.There was resistance while advancing the balloon on the wire.The device was not returned for analysis.A device history record (dhr) review of lot 17502612 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿guidewire lumen resistance/friction - during prep¿ and ¿pta/ptca system separated - during prep¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Based on the limited information provided, procedural/handling (needing more lubricity) may have contributed to the reported event.According to the instructions for use (ifu), ¿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 dhr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken.

Event Description

As reported, during prep, the saber (2.5mm4cm 150) balloon became stuck to the guidewire and detached from the device.There was no reported patient injury.The product was not clinically used and not will be returned for analysis.The product was stored, handled, inspected and prepped according to the ifu.There was no difficulty experienced when removing the device from its packaging.There was no difficulty in removing the stylet or any of the sterile packaging components, the product from the hoop, or the protective balloon cover.The device looked normal when taken from its packaging.There were kinks or other damages noted while advancing balloon on wire.The same indeflator was used successfully with other devices.There was resistance while advancing the balloon on the wire.When resistance was felt while advancing the balloon on the wire, the physician attempted to retracted the device in order to wipe the wire for more lubricity; however, at that moment a part of the balloon detached on the table.

Manufacturer Narrative

Complaint conclusion: as reported, during prep, the 2.5x40mm 150cm saber balloon catheter became stuck to the guidewire and detached from the device.There was no reported patient injury.The product was stored, handled, inspected and prepped according to the ifu.There was no difficulty experienced when removing the device from its packaging.There was no difficulty in removing the stylet or any of the sterile packaging components, the product from the hoop, or the protective balloon cover.The device looked normal when taken from its packaging.There were kinks or other damages noted while advancing balloon on wire.The same indeflator was used successfully with other devices.There was resistance while advancing the balloon on the wire.When resistance was felt while advancing the balloon on the wire, the physician attempted to retracted the device in order to wipe the wire for more lubricity; however, at that moment a part of the balloon detached on the table.One non-sterile unit of saber 2.5mm4cm 150 was received coiled inside a plastic bag.Per visual analysis, it was noticed that the balloon was not previously inflated/deflated and the distal tip of the balloon device was found separated (the distal tip was not received for analysis).No other damages were noted in the device during visual analysis.A dimensional analysis to measure the distal tip¿s inner lumen id could not be performed due to the separated conditions that show elongation characteristics.A functional analysis was performed.A 0.018 guidewire was inserted through the saber guidewire lumen and the guidewire went through without resistance/friction felt.The separated tip was inspected under microscope and it was noticed that the separated edges presented evidence of elongations.The unit was sent to sem analysis in order to find the potential cause of the tip separation.Sem analysis results also showed that the proximal separated section of tip presented evidence of elongations.The elongations observed suggests that the device was induced to stretching/pulling events that exceeded the material¿s yield strength prior to the separation.No other issues were noted during sem analysis.A device history record (dhr) review of lot 17502612 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿guidewire lumen resistance/friction during prep¿ was not confirmed since no resistance friction was felt during the functional analysis and the guidewire used with the device was not returned.However, the reported ¿pta/ptca system separated during prep¿ was confirmed through analysis of the returned device.The root cause of the saber tip separation could not be conclusively determined during the analysis.Based on the limited information available for review, concomitant device factors, such as lubricity and condition of the guidewire, and handling factors likely contributed to the separation as evidenced by the presence of elongations and frayed edges noted during sem analysis.According to the instructions for use, which is not intended as a mitigation, ¿when the catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation.Do not advance or retract the catheter unless the balloon is fully deflated under vacuum.If resistance is met during manipulation, determine the cause of resistance before proceeding.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 dhr 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.

• Brand Name: SABER 2.5MM4CM 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
• MDR Report Key: 6949859
• MDR Text Key: 90305015
• Report Number: 9616099-2017-01508
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K971010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/17/2017

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: 04/30/2019
• Device Model Number: 48002504X
• Device Catalogue Number: 48002504X
• Device Lot Number: 17502612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2017
• Initial Date FDA Received: 10/13/2017
• Supplement Dates Manufacturer Received: 09/20/2017
• Supplement Dates FDA Received: 11/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2016
• 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