MAUDE Adverse Event Report: CORDIS CORPORATION MAXI LD 7F 15X4 80CM; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4171540S
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	07/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt this device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the maxi ld 7f 15x4 balloon ruptured and some of the balloon material separated from the balloon.The separated material was retrieved from the opposite side with a snare.There was no reported injury to the patient.The device will be returned for evaluation.
Additional Manufacturer Narrative
As reported, the maxi ld 7f 15x4 balloon ruptured and some of the balloon material separated from the balloon.The separated material was retrieved from the opposite side with a snare.There was no reported injury to the patient.One product was returned for analysis.A non-sterile maxi ld 7f 15x4 80cm was received for analysis inside a plastic bag.Per visual analysis, a separation in the balloon and a separation on the outer and inner body of the unit was observed the way the maxi ld was returned for evaluation.No other anomalies were noted.Functional analysis could not be performed on the unit due to the separated/ruptured condition of the maxi ld in which it was received for evaluation.Per microscopic analysis, sem analysis was performed to the received maxi ld unit to identify the possible root cause of the separated conditions.Sem results showed that the separated areas of the maxi ld 7f 15x4 80cm presented evidence of rupture and deformation in the area of the balloon.In addition, a twisted condition and fractured/exposed wire on the outer and inner body of the unit were noted.These separated conditions are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the unit¿s material was induced to a tensile force that exceeded the yield strength prior to the separations.No other anomalies were observed during the sem analysis.A product history record (phr) review of lot 82233172 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst¿ and ¿balloon- separated - in-patient¿ were confirmed during device analysis.However, the exact cause of the reported events cannot be determined.Sem results showed that the separated area on the inner and outer body and the balloon presented evidence of ruptures and deformations.It appears the inner/outer shaft material was induced to a tensile force that exceeded the material yield strength prior to the separation.With the limited amount of details provided and based on the information available for review, it is likely vessel characteristics and handling of the device contributed to the reported events as evidenced by device analysis.According to 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 limited 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 maxi ld 7f 15x4 balloon ruptured and some of the balloon material separated from the balloon.The separated material was retrieved from the opposite side with a snare.There was no reported injury to the patient.The device will be returned for evaluation.Additional information was requested; however, the information was not obtained after multiple attempts.

• Brand Name: MAXI LD 7F 15X4 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: 15264902
• Report Number: 9616099-2022-05907
• Device Sequence Number: 14922926
• Product Code: LIT
• UDI-Device Identifier: 20705032002506
• UDI-Public: (01)20705032002506(17)230228(10)82233172
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 4171540S
• Device Catalogue Number: 4171540S
• Device Lot Number: 82233172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2022
• Supplement Date Received by Manufacturer: 08/22/2022
• Initial Report FDA Received Date: 08/22/2022
• Supplement Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2021
• 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: UNK SNARE
• Outcome Attributed to Adverse Event: Required Intervention; Other; Life Threatening
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 112 KG