MAUDE Adverse Event Report: CORDIS CASHEL SABER 2.5MM15CM 150; PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER

Model Number N/A

Device Problems Burst Container or Vessel (1074); Detachment Of Device Component (1104); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2018

Event Type  Injury  

Manufacturer Narrative

During a post-atherectomy procedure with a 2.5 x 150 mm 150 cm saber percutaneous transluminal angioplasty (pta) balloon catheter in the peroneal artery, the balloon ruptured either during inflation or when trying to remove the device.Additionally, there was resistance met while withdrawing the device into the guide catheter.The balloon was caught on the catheter and was snared out after unsuccessful attempts were made to jail it with stents.The balloon was initially inflated to nominal pressure or below before rupture.The physician attempted to jail it with a stent and also with a second stent before it was snared out.The reason for the procedure was to improve blood flow to the foot.There lesion was moderately calcified, a little angulation, 70% occluded and there was no vessel tortuosity.There were no anomalies noted when removed from the package and no anomalies noted during prep.The device was not inserted through a stopcock instead of a hemostatic valve.The patient is doing well.A non-sterile saber 2.5 mm 15 cm 150 catheter was received coiled inside a plastic bag.Per visual analysis, the balloon of the catheter was received ruptured/separated.The distal part of the balloon was not returned for analysis.Blood residues were observed on the unit.No other anomalies observed.Functional analysis, such as the leak test or the insertion/ withdrawal test, could not be performed due to the ruptured and separated condition of the balloon catheter received.The device was sent for sem analysis to identify the cause of the balloon rupture/separation.Results showed that the external surface of balloon presented evidence of scratches and abrasion marks near the balloon rupture and it¿s very likely that the same factors that caused these damages on the balloon¿s outer surface could have also contributed to the burst/rupture found on the received balloon.The internal surface did not present any evidence of damages.No other anomalies were found during the analysis.A device history record (dhr) review of lot 17643812 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst at/below rbp,¿ ¿balloon separated in patient,¿ and ¿balloon withdrawal difficulty through guide/sheath¿ were confirmed through analysis of the returned device.However, the exact cause of the balloon rupture, withdrawal difficulty and separation could not be conclusively determined during analysis.Based on the limited information available for review, vessel characteristics (moderately calcified vessel below the knee) and handling/procedural factors may have contributed to the balloon burst, withdrawal difficulty and subsequent separation reported as evidenced by the scratches and abrasion noted during sem analysis.According to the instructions for use, which is not intended as a mitigation, ¿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.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.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.

Event Description

During post atherectomy with a 2.5 mm 15 cm 150 saber percutaneous transluminal angioplasty (pta) balloon catheter in peroneal artery, the balloon ruptured either during inflation or when trying to remove.The balloon was caught on catheter and was snared out after unsuccessful attempts were made to jail it with stents.The balloon was initially inflated to nominal or below.The physician attempted to jail it with a stent and also with a second stent before it was snared out.The device will be returned for analysis.The reason for the procedure was to improve blood flow to the foot.There was resistance met while withdrawing the device into the guide catheter.There lesion was moderately calcified, a little angulation, 70% occluded and there was no vessel tortuosity.There were no anomalies noted when removed from the package and no anomalies noted during prep.The device was not inserted through a stopcock instead of a hemostatic valve.The patient is doing well.A procedural cd was requested and is not available.

• Brand Name: SABER 2.5MM15CM 150
• Type of Device: PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER
• Manufacturer (Section D): CORDIS CASHEL; cahir road; co. tipperary; cashel ; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; co. tipperary; cashel ; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 7293242
• MDR Text Key: 100835117
• Report Number: 9616099-2018-01930
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 48002515X
• Device Lot Number: 17643812
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/29/2018
• Date Manufacturer Received: 01/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2017
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 79 YR