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

Model Number	4171640S
Medical Device Problem Codes	Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, two 7f 16x4 maxi ld balloons ruptured during post dilatation of venous stent.The balloons were only inflated to 4 atm before rupturing.Upon removal of the second device, the balloon completely separated.This occurred while trying to remove the balloon from the sheath.The sheath had to be removed with balloon and wire, sheath then had to be cut open to remove the balloon.There was no reported injury to the patient.The devices will not be returned for evaluation as an image was provided.
Additional Manufacturer Narrative
This report is related to report # 3007635982-2023- 00161.A review of the manufacturing documentation associated with lot 82258074 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 or Problem Description
As reported, two 7f 16x4 maxi ld balloons ruptured during post dilatation of venous stent.The balloons were only inflated to 4 atm before rupturing.Upon removal of the second device, the balloon completely separated.This occurred while trying to remove the balloon from the sheath.The sheath had to be removed with balloon and wire, sheath then had to be cut open to remove the balloon.There was no reported injury to the patient.The devices will not be returned for evaluation as an image was provided.
Additional Manufacturer Narrative
This report is related to report # (b)(4).After further review of additional information received the following sections have been updated accordingly: b5, g3, h1, h2, h3 and h6 as reported, two 7f 16x4 maxi ld balloons ruptured during post dilatation of venous stent.The balloons were only inflated to 4 atm before rupturing.Upon removal of the second device, the balloon completely separated.This occurred while trying to remove the balloon from the sheath.The sheath had to be removed with balloon and wire, sheath then had to be cut open to remove the balloon.There was no reported injury to the patient.The picture shows the distal section of the 2 units.Sample # 1, it could be noticed the balloon deflated and blood residues.Sample # 2, it could be noticed the balloon burst and separated.No other anomalies of the product can be noticed at the attached picture.The devices were not returned for analysis.One image was provided for review.Per visual analysis of the images: the picture shows the distal section of the 2 units: sample#1: it could be noticed the balloon deflated and blood residues.Sample#2: it could be noticed the balloon burst and separated.A product history record (phr) review of the lot for both devices, 82258074, revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst¿ could not be confirmed on sample 1 as the image showed depicted a deflated balloon.The reported ¿balloon burst¿ was confirmed for sample 2 upon review of the image.With the limited information provided and without return of the devices an exact cause for the event could not be determined.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.
Event or Problem Description
As reported, two 7f 16x4 maxi ld balloons ruptured during post dilatation of venous stent.The balloons were only inflated to 4 atm before rupturing.Upon removal of the second device, the balloon completely separated.This occurred while trying to remove the balloon from the sheath.The sheath had to be removed with balloon and wire, sheath then had to be cut open to remove the balloon.There was no reported injury to the patient.The devices will not be returned for evaluation as an image was provided.The picture shows the distal section of the 2 units.Sample # 1, it could be noticed the balloon deflated and blood residues.Sample # 2, it could be noticed the balloon burst and separated.No other anomalies of the product can be noticed at the attached picture.

• Brand Name: MAXI LD
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; coyol free zone, building b25, , , costa rica; el coyol alajuela bld 25 ; 7863138372
• MDR Report Key: 16794241
• Report Number: 3007635982-2023-00159
• Device Sequence Number: 6861126
• Product Code: LIT
• UDI-Device Identifier: 20705032002568
• UDI-Public: (01)20705032002568(17)240229(10)82258074
• Combination Product (Y/N): N
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/30/2023

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
• Device Expiration Date: 02/29/2024
• Device Model Number: 4171640S
• Device Catalogue Number: 4171640S
• Device Lot Number: 82258074
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/22/2023; 06/27/2023
• Initial Report FDA Received Date: 04/24/2023
• Supplement Report FDA Received Date: 06/15/2023; 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/09/2022
• 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: USED WITH BOSTON VENOUS WALLSTENT.
• Patient Sex: Unknown