MAUDE Adverse Event Report: CORDIS CORPORATION MAXI LD 7F 14X4 80CM; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4171440S
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product history review is expected but has not been completed.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, after an unknown stent was implanted, two 7f maxi ld 14x4 80cm balloons ruptured.The first maxi balloon was used, but it ruptured at 4 atm.A second maxi (same size) was used, and it ruptured in the same area at 4 atm.There was no reported patient injury.This occurred during a left venogram.The device were disposed/discarded.
Event or Problem Description
As reported, after an unknown stent was implanted, two 7f maxi ld 14x4 80cm balloons ruptured.The first maxi balloon was used, but it ruptured at 4 atm.A second maxi (same size) was used, and it ruptured in the same area at 4 atm.There was no reported patient injury.This occurred during a left venogram.The device were disposed/discarded.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b4, d4, g3, h1, h2, h3 and h6 as reported, after an unknown stent was implanted, two 7f maxi ld 14x4 80cm balloons ruptured.The first maxi balloon was used, but it ruptured at 4 atm.A second maxi (same size) was used, and it ruptured in the same area at 4 atm.There was no reported patient injury.This occurred during a left venogram.The devices were not returned for evaluation as they were discarded.A product history record (phr) review of the lot for both devices, 82248652, 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.With the limited information provided an exact cause could not be determined.Without the return of the device for analysis, it is difficult to draw a clinical conclusion between the device and the event reported.With the limited information provided pertaining to the vessel/lesion characteristics, it is not possible to determine an exact cause for the event.However, interaction between the previously implanted stent and the balloon can create circumstances in which the balloon may burst.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.To reduce the potential for vessel damage, the inflated diameter of the balloon should approximate the diameter of the vessel just proximal and distal to the stenosis.¿ 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.

• Brand Name: MAXI LD 7F 14X4 80CM
• Common Device Name: 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 Key: 16461633
• Report Number: 9616099-2023-06282
• Device Sequence Number: 15093264
• Product Code: LIT
• UDI-Device Identifier: 20705032002438
• UDI-Public: (01)20705032002438(17)231130(10)82248652
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K963000
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2023

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: 11/30/2023
• Device Model Number: 4171440S
• Device Catalogue Number: 4171440S
• Device Lot Number: 82248652
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2023
• Supplement Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 03/15/2023
• Date Device Manufactured: 06/06/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN STENT
• Patient Age: 67 YR
• Patient Sex: Female