MAUDE Adverse Event Report: CORDIS US. CORP MAXI LD; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4161440L
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2023
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, the doctor reported that the maxi ld 14x4 balloon burst after being inflated respecting the nominal pressure.There was no reported injury to the patient.Additional information and device return was requested; however, both were not obtained after multiple attempts made.
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 a review of the manufacturing documentation associated with lot 82246340 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, the doctor reported that the maxi ld 14x4 balloon burst after being inflated respecting the nominal pressure.There was no reported injury to the patient.Additional information and device return was requested; however, both were not obtained after multiple attempts made.
Additional Manufacturer Narrative
As reported, the doctor reported that the maxi ld 14x4 balloon burst after being inflated respecting the nominal pressure.There was no reported injury to the patient.Additional information was requested; however, was not obtained after multiple attempts made.The device was not returned for analysis after multiple attempts were made.A product history record (phr) review of lot 82246340 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 device was not returned for analysis.The exact cause could not be determined.There is no additional information regarding patient, lesion, or procedural characteristics regarding this event.With the limited amount of information available and without the return of the product for analysis it is difficult to draw a clinical conclusion between the device and the event reported.Nevertheless, it is likely vessel characteristics and procedural factors contributed to the reported event.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 doctor reported that the maxi ld 14x4 balloon burst after being inflated respecting the nominal pressure.There was no reported injury to the patient.Additional information and device return was requested; however, both were not obtained after multiple attempts made.Two images were noted on the file.On the first image the pouch of a maxi ld ref 416-1440l lot 82246340 is noted.On the second image a plastic bag with the device inside is observed, however the unit cannot be inspected, thus no anomalies were noted.

• Brand Name: MAXI LD
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 16486772
• Report Number: 9616099-2023-06301
• Device Sequence Number: 6919484
• Product Code: LIT
• UDI-Device Identifier: 20705032002063
• UDI-Public: (01)20705032002063(17)230831(10)82246340
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/15/2023

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: 08/31/2023
• Device Model Number: 4161440L
• Device Catalogue Number: 4161440L
• Device Lot Number: 82246340
• 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: 02/08/2023
• Supplement Date Received by Manufacturer: 03/15/2023; 05/10/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 04/12/2023; 05/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/14/2022
• 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