MAUDE Adverse Event Report: CORDIS CASHEL MAXI LD; 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	04/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the 7f maxi ld 14x4 balloon ruptured during a case.It never achieved pressure.This balloon simply ruptured before any significant pressure was attained.Nothing out of the ordinary.There was no reported injury to the patient.The device will be returned for evaluation.
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.This device is available for analysis but has not yet been received.
Additional Manufacturer Narrative
The 7f maxi ld 14x4 balloon ruptured during a case.It never achieved pressure.This balloon simply ruptured before any significant pressure was attained.Nothing out of the ordinary.There was no reported injury to the patient.The product was not returned for analysis.A product history record (phr) review of lot 82264258 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 as the device was not returned for analysis.The exact cause could not be determined.Procedural or handling factors or vessel characteristics (although unknown) may have contributed to the reported event as the presence of calcification is known to cause damage to balloons.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.¿ neither the phr review nor the limited information provided 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 or Problem Description
As reported, the 7f maxi ld 14x4 balloon ruptured during a case.It never achieved pressure.This balloon simply ruptured before any significant pressure was attained.Nothing out of the ordinary.There was no reported injury to the patient.The device will not be returned for evaluation.

• 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: 16896743
• Report Number: 3007635982-2023-00176
• Device Sequence Number: 12284981
• Product Code: LIT
• UDI-Device Identifier: 20705032002438
• UDI-Public: (01)20705032002438(17)240430(10)82264258
• Combination Product (Y/N): N
• 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): Unknown
• 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): 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
• Device Expiration Date: 04/30/2024
• Device Model Number: 4171440S
• Device Catalogue Number: 4171440S
• Device Lot Number: 82264258
• 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: 05/24/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2022
• 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: UNKOWN
• Patient Sex: Unknown