MAUDE Adverse Event Report: CORDIS CASHEL SABER RX4MM2CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 51004002L

Device Problems Burst Container or Vessel (1074); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/12/2017

Event Type  Injury  

Manufacturer Narrative

The product is being returned for analysis, however has not yet been received.A device history record (dhr) review of revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.

Event Description

As reported, the saber rx 4mm2cm155 percutaneous transluminal angioplasty (pta) balloon catheter was delivered to the lesion and inflated; however, it ruptured.As the physician attempted to remove the saber pta it separated at its balloon part.The guide liner was also separated and a snare catheter was advanced to remove the separated fragments.However, the snare catheter could not remove them and a surgical operation was performed.There was no reported patient injury.The device was stored and handled per the instructions for use (ifu).The device was prepped per the ifu.There were no anomalies noted when the device was removed from the packaging.There was no difficulty removing the stylet or any of the sterile packaging components.There was no difficulty removing the product from the hoop.There was no difficulty removing the protective balloon cover.The device prepped normally (i.E.Maintain negative pressure).There were no kinks nor other damages noted prior to inserting the product the product into the patient.The product was clinically used and it will be returned for analysis.The patient¿s information was unknown.The target lesion was the superficial femoral artery.The patient¿s vessel level of tortuousness was unknown.The lesion was heavily calcified.The rate of stenosis was unknown.

Manufacturer Narrative

Complaint conclusion: the saber rx 4mm2cm155 percutaneous transluminal angioplasty (pta) balloon catheter was delivered to the lesion and inflated; however, it ruptured.As the physician attempted to remove the saber pta it separated at its balloon part.The guide liner was also separated and a snare catheter was advanced to remove the separated fragments.However, the snare catheter could not remove them and a surgical operation was performed.There was no reported patient injury.The patient¿s information was unknown.The target lesion was the superficial femoral artery.The patient¿s vessel level of tortuousness was unknown.The lesion was heavily calcified.The rate of stenosis was unknown.The device was stored and handled per the instructions for use (ifu).The device was prepped per the ifu.There were no anomalies noted when the device was removed from the packaging.There was no difficulty removing the stylet or any of the sterile packaging components.There was no difficulty removing the product from the hoop.There was no difficulty removing the protective balloon cover.The device prepped normally (i.E.Maintain negative pressure).There were no kinks nor other damages noted prior to inserting the product the product into the patient.A non-sterile saber rx4mm2cm155 was received coiled inside of a clear plastic bag.Product was remove from the plastic bag to do a first visual inspection without any optical magnifying device.Part was received divided into three sections, due to two separations at the body shaft located at 23 and 120 cm from the distal tip end.Also, a kinked/bent condition was observed at 36 cm from the distal tip.Balloon was blood-saturated.One guidewire was found already inserted through the distal tip end.Functional test was performed.Due to the saber received in three segments, a ¿y¿ connector was utilized to perform the inflation test.The inflator/deflator device was attached to the ¿y¿ connector.Device¿s nominal pressure is 8 atm.Balloon inflation process was done by applying pressure with the inflator/deflator device.When manometer indicate the nominal pressure of 8 atm, a leakage was observed and the balloon pressure decreased.During the sem analysis, a balloon leakage was observed at the balloon¿s proximal section, and at the body separated sections.The balloon¿s outer and inner surfaces were scanned to identify the possible root cause of the leakage.Also the separated area were scanned to identify the possible root cause of the separation.Sem results showed the leakage was caused by a rupture on the balloon¿s proximal section, the external surface of the balloon presented evidence of abrasions and scratch marks near the balloon rupture.It¿s very likely that the same factors that caused the abrasions and scratch marks on the balloon¿s outer surface can also contribute to the rupture found on the received balloon.The internal surface of balloon did not present any evidence of damages.No other anomalies were found during the analysis.The body/shaft separated sections presented evidence of material deformation and 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 17274307 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon separated - in-patient¿ was confirmed through analysis of the returned device.The reported ¿balloon burst¿ was not confirmed due to the technical definition of a burst, however a leakage was confirmed, which may appear to the user as a burst, through analysis of the returned device.The exact cause of the burst and separations could not be determined during analysis.Based on the limited information available for review, vessel characteristics of heavy calcification may have contributed to the burst reported as evidenced by the abrasions and scratch marks noted around the rupture during sem analysis.Handling/procedural factors likely contributed to the separation reported as evidenced by the material deformation and elongations noted at the separated sections during sem analysis.According to the instructions for use, which is not intended as a mitigation, ¿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.Do not exceed the rated burst pressure recommended on the label.The rated burst pressure is based on the results of in vitro testing.At least 99.9% of the balloons (with a 95% confidence) will not burst at or below their rated burst pressure.Use of a pressure monitoring device is recommended to prevent over-pressurization.Pressure in excess of the rated burst pressure can cause balloon rupture and potential inability to withdraw the catheter through the introducer sheath.Balloon rupture can cause vessel damage and the need for additional intervention.Use only the recommended balloon inflation medium (a 50/50 mixture by volume of contrast medium and normal saline).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 RX4MM2CM155
• 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: 6767272
• MDR Text Key: 81826313
• Report Number: 9616099-2017-01295
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 09/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: 51004002L
• Device Catalogue Number: 51004002L
• Device Lot Number: 17274307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2015
• 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
• Patient Outcome(s): Required Intervention