MAUDE Adverse Event Report: CORDIS CORPORATION MAXI LD; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4171860S
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product history record review is anticipated; however, it has not yet been finalized.Additional information is pending and will be submitted within 30 days upon receipt.This case is related to fda report number 9616099-2023-06320.
Event or Problem Description
As reported, the balloons of two (2) 7f 18mm x 6mm x 80cm maxi ld percutaneous transluminal angioplasty (pta) balloon catheters burst during angioplasty of the iliac vein.The balloon burst occurred during initial inflation at 4 atmospheres (atm).The devices did not inflate normally; leakage was noted from the balloon.There was no reported patient injury.There was moderate target lesion vessel calcification and mild vessel tortuosity.The percentage stenosis was not provided.The device was not being used for a chronic total occlusion.The devices were prepped as per the instructions for use (ifu).The products were properly stored and opened in sterile field.There were no visible signs of device/package damage prior to use.The devices prepped normally maintaining negative pressure.The catheter was not torqued against resistance.There were no kinks/bends noted after the devices were removed from patient.No unusual force was used at any time during the procedure.The devices were removed intact (in one piece) from the patient.The user is trained to the device.The devices will not be returned for evaluation.
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82250909 presented no issues during the manufacturing process that could be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the balloons of two (2) 7f 18mm x 6mm x 80cm maxi ld percutaneous transluminal angioplasty (pta) balloon catheters burst during angioplasty of the iliac vein.The balloon burst occurred during initial inflation at 4 atmospheres (atm).The devices did not inflate normally; leakage was noted from the balloon.There was no reported patient injury.There was moderate target lesion vessel calcification and mild vessel tortuosity.The percentage stenosis was not provided.The device was not being used for a chronic total occlusion.The devices were prepped as per the instructions for use (ifu).The products were properly stored and opened in sterile field.There were no visible visible signs of device/package damage prior to use.The devices prepped normally maintaining negative pressure.The catheter was not torqued against resistance.There were no kinks/bends noted after the devices were removed from patient.No unusual force was used at any time during the procedure.The devices were removed intact (in one piece) from the patient.The user is trained to the device.The devices will not be returned for evaluation.
Additional Manufacturer Narrative
As reported, the balloons of two (2) 7f 18mm x 6mm x 80cm maxi ld percutaneous transluminal angioplasty (pta) balloon catheters burst during angioplasty of the iliac vein.The balloon burst occurred during initial inflation at four atmospheres (atm).The devices did not inflate normally; leakage was noted from the balloon.There was no reported patient injury.There was moderate target lesion vessel calcification and mild vessel tortuosity.The percentage stenosis was not provided.The device was not being used for a chronic total occlusion.The devices were prepped as per the instructions for use (ifu).The products were properly stored and opened in sterile field.There were no visible signs of device/package damage prior to use.The devices prepped normally maintaining negative pressure.The catheter was not torqued against resistance.There were no kinks/bends noted after the devices were removed from patient.No unusual force was used at any time during the procedure.The devices were removed intact (in one piece) from the patient.The user is trained to the device.2023-00044-1 the device was not returned for analysis.A product history record (phr) review of lot 82250909 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.2023-00044-2 the device was not returned for analysis.A product history record (phr) review of lot 82250909 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 devices were not returned for analysis.The exact cause could not be determined.Vessel characteristics of mild tortuosity along with calcification and procedural factors likely contributed to the reported event.However, without the return of the products for analysis it is difficult to draw a clinical conclusion between the devices and the event reported.According to the safety information in the instructions for use ¿note: the rated burst pressure is printed on the package label.In vitro testing has shown that with 95% confidence, 99.9% of the balloons will not burst at or below the rated pressure.Balloons should not be inflated in excess of the rated burst pressure.Prior to angioplasty, the catheter should be examined to verify functionality and ensure that its size and shape are suitable for the specific procedure for which it is to be used.Carefully advance the catheter through a sheath or through the percutaneous entry site.Note: gentle counterclockwise rotation of the balloon may ease introduction through the sheath or percutaneous entry site.Note: perform all further catheter manipulations under fluoroscopy.Carefully advance the catheter to the selected site.Caution: if strong resistance is met during advancement or withdrawal of the catheter, discontinue movement, and determine the cause of resistance before proceeding.If the cause of resistance cannot be determined, withdraw the entire system.¿ 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.
Event or Problem Description
As reported, the balloons of two (2) 7f 18mm x 6mm x 80cm maxi ld percutaneous transluminal angioplasty (pta) balloon catheters burst during angioplasty of the iliac vein.The balloon burst occurred during initial inflation at 4 atmospheres (atm).The devices did not inflate normally; leakage was noted from the balloon.There was no reported patient injury.There was moderate target lesion vessel calcification and mild vessel tortuosity.The percentage stenosis was not provided.The device was not being used for a chronic total occlusion.The devices were prepped as per the instructions for use (ifu).The products were properly stored and opened in sterile field.There were no visible visible signs of device/package damage prior to use.The devices prepped normally maintaining negative pressure.The catheter was not torqued against resistance.There were no kinks/bends noted after the devices were removed from patient.No unusual force was used at any time during the procedure.The devices were removed intact (in one piece) from the patient.The user is trained to the device.The devices will not be returned for evaluation.

• Brand Name: MAXI LD
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer Contact: karla castro ; 14201 nw 60th avenue; miami lakes, FL 33014-2802 ; 7863138372
• MDR Report Key: 16526465
• Report Number: 9616099-2023-06322
• Device Sequence Number: 17457685
• Product Code: LIT
• UDI-Device Identifier: 20705032002629
• UDI-Public: (01)20705032002629(17)231231(10)82250909
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K023907
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/08/2023

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: 12/31/2024
• Device Model Number: 4171860S
• Device Catalogue Number: 4171860S
• Device Lot Number: 82250909
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2023
• Supplement Date Received by Manufacturer: 03/17/2023; 06/08/2023
• Initial Report FDA Received Date: 03/10/2023
• Supplement Report FDA Received Date: 04/19/2023; 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/04/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown