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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION SLALOM PTA .018 HP 40 3X4; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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CORDIS CORPORATION SLALOM PTA .018 HP 40 3X4; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number 4393040T
Device Problem Burst Container or Vessel (1074)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/11/2022
Event Type  malfunction  
Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82223664 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported, after being delivered to the lesion, the balloon of a 3mm x 4mm 40 slalom.018 high pressure (hp) percutaneous transluminal angioplasty (pta) balloon catheter ruptured during an inflation to 10 atmospheres (atm) with an indeflator inflation device.As a result, the 3mm x 4mm 40 slalom pta balloon catheter was replaced with an unknown device to complete the procedure.There was no reported injury to the patient.This was during a procedure to treat an av shunt.The lesion had a 90% stenosis and was severely calcified with moderate tortuosity present.The lesion was not a chronic total occlusion (cto).The device was stored and prepped per the instructions for use (ifu) and maintained negative pressure during preparation.There was no difficulty removing the device from the hoop, removing the protective balloon cover, the stylet, or any of the sterile packaging components and the device was not kinked or damaged in any way prior to being inserted into the patient.There was no resistance or friction experienced during insertion of the device.The device was able to track towards the lesion and cross the lesion without difficulty.The device was never put into an acute bend and did not kink during its use.After the rupture occurred, the balloon catheter was able to be removed easily and remained in one piece during its removal.Information regarding the patient, contrast used, contrast to saline ratio, and the replacement device used was requested but not provided.The device was discarded and will not be returned.
 
Event Description
As reported, after being delivered to the lesion, the balloon of a 3mm x 4mm 40 slalom.018 high pressure (hp) percutaneous transluminal angioplasty (pta) balloon catheter ruptured during an inflation to 10 atmospheres (atm) with an indeflator inflation device.As a result, the 3mm x 4mm 40 slalom pta balloon catheter was replaced with an unknown device to complete the procedure.There was no reported injury to the patient.This was during a procedure to treat an av shunt.The lesion had a 90% stenosis and was severely calcified with moderate tortuosity present.The lesion was not a chronic total occlusion (cto).The device was stored and prepped per the instructions for use (ifu) and maintained negative pressure during preparation.There was no difficulty removing the device from the hoop, removing the protective balloon cover, the stylet, or any of the sterile packaging components and the device was not kinked or damaged in any way prior to being inserted into the patient.There was no resistance or friction experienced during insertion of the device.The device was able to track towards the lesion and cross the lesion without difficulty.The device was never put into an acute bend and did not kink during its use.After the rupture occurred, the balloon catheter was able to be removed easily and remained in one piece during its removal.Information regarding the patient, contrast used, contrast to saline ratio, and the replacement device used was requested but not provided.The device was discarded and will not be returned.
 
Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b3, g3, g4, g6, h1, h2, h3, h6, and h10.Complaint conclusion: as reported, after being delivered to the lesion, the balloon of a 3mm x 4mm 40 slalom.018 high pressure (hp) percutaneous transluminal angioplasty (pta) balloon catheter ruptured during an inflation to 10 atmospheres (atm) with an indeflator inflation device.As a result, the 3mm x 4mm 40 slalom pta balloon catheter was replaced with an unknown device to complete the procedure.There was no reported injury to the patient.This was during a procedure to treat an av shunt.The lesion had a 90% stenosis and was severely calcified with moderate tortuosity present.The lesion was not a chronic total occlusion (cto).The device was stored and prepped per the instructions for use (ifu) and maintained negative pressure during preparation.There was no difficulty removing the device from the hoop, removing the protective balloon cover, the stylet, or any of the sterile packaging components and the device was not kinked or damaged in any way prior to being inserted into the patient.There was no resistance or friction experienced during insertion of the device.The device was able to track towards the lesion and cross the lesion without difficulty.The device was never put into an acute bend and did not kink during its use.After the rupture occurred, the balloon catheter was able to be removed easily and remained in one piece during its removal.Information regarding the patient, contrast used, contrast to saline ratio, and the replacement device used was requested but not provided.The device was not returned for analysis as it was discarded.A product history record (phr) review of lot 82223664 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¿ could not be confirmed as the device was not returned for analysis.The exact cause of the reported event could not be determined.The procedure performed was a shunt percutaneous transluminal angioplasty (pta) case.Arteriovenous shunts are often scarred and fibrous in nature and therefore often resistant to balloon expansion increasing the likelihood of damage to the balloon.Additionally, the lesion was described as severely calcified with tortuosity and stenosis, which are likely contributing factors as well.However, without the return of the device for analysis it is difficult to draw a clinical conclusion between the device and the event reported.According to the instructions for use ¿if resistance is met during manipulation, determine the cause of the resistance before proceeding.Balloon pressure should not exceed the rated burst pressure.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.Use only the recommended balloon inflation medium.Never use air or any gaseous medium to inflate the balloon.¿ 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.
 
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Brand Name
SLALOM PTA .018 HP 40 3X4
Type of Device
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer Contact
karla castro
14201 nw 60 avenue
miami lakes, FL 33014
7863138372
MDR Report Key14620393
MDR Text Key293864706
Report Number9616099-2022-05695
Device Sequence Number1
Product Code LIT
UDI-Device Identifier20705032061589
UDI-Public(01)20705032061589(17)240531(10)82223664
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K003159
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number4393040T
Device Lot Number82223664
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/10/2022
Date Device Manufactured06/01/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
UNK DEVICE
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