MAUDE Adverse Event Report: CORDIS US. CORP MAXI LD 14X6 80CM PTA BALLOON CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4171460S
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2023
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, during the use of a 14x6 80cm maxi ld percutaneous transluminal angioplasty (pta) balloon catheter, the balloon immediately ruptured during an attempted inflation and the balloon was unable to be pressurized.As a result, a new 14x6 80cm maxi ld pta balloon catheter was used as a replacement.There was no reported injury to the patient.The device was being used to post dilate an unknown venous stent.There was no difficulty removing the stylet or any of the sterile packaging components.A 1:2 contrast to saline ratio was used to prep the balloon.The device was able to be removed easily from the patient and remained in one piece during its removal.The device will not be returned for evaluation.
Additional Manufacturer Narrative
Complaint conclusion: as reported, during the use of a 14x6 80cm maxi ld percutaneous transluminal angioplasty (pta) balloon catheter, the balloon immediately ruptured during an attempted inflation and the balloon was unable to be pressurized.As a result, a new 14x6 80cm maxi ld pta balloon catheter was used as a replacement.There was no reported injury to the patient.The device was being used to post dilate an unknown venous stent.There was no difficulty removing the stylet or any of the sterile packaging components.A 1:2 contrast to saline ratio was used to prep the balloon.The device was able to be removed easily from the patient and remained in one piece during its removal.The product was not returned for analysis.A product history record (phr) review of lot 82266684 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.

• Brand Name: MAXI LD 14X6 80CM PTA BALLOON CATHETER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, florida 33014 ; 7863138372
• MDR Report Key: 16665737
• Report Number: 3007635982-2023-00121
• Device Sequence Number: 5934291
• Product Code: LIT
• UDI-Device Identifier: 20705032002452
• UDI-Public: (01)20705032002452(17)240430(10)82266684
• 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): 04/21/2023

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: 4171460S
• Device Catalogue Number: 4171460S
• Device Lot Number: 82266684
• 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: 03/09/2023
• Supplement Date Received by Manufacturer: 04/14/2023
• Initial Report FDA Received Date: 04/03/2023
• Supplement Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2022
• 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: 14X6 80CM MAXI LD PTA BALLOON CATHETER
• Patient Sex: Unknown