MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO MAXI LD PTA F7 110 25X40; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4162540L
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is pending and will be sent in upon 30 days after receipt.
Event or Problem Description
As reported, the maxi ld pta f7 110 25x40 balloon dilatation catheter was used.However, when inflated at 3 atmospheres (atm), contrast media leakage was confirmed.Judged as a balloon rupture and it was removed from the patient body.Therefore, the device was replaced with a new maxi ld and the procedure was completed.There was no reported patient injury.The lesion was the inferior vena cava with stenosis.A device was stored in-hospital sanitary area storage.It was opened cath room and appearance.No damage was seen on the sterilization bag.Completed device flushing and deflating.They¿ve checked the stenosis part and pre-dilation was performed with a non-cordis balloon catheter second time.The device will not be returned for evaluation because it was discarded due to hospital regulation.Additional procedural details were requested but are unknown.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2 and h6 have been updated accordingly.As reported, the maxi ld pta f7 110 25x40 balloon dilatation catheter was used.However, when inflated at three atmospheres (atm), contrast media leakage was confirmed.Judged as a balloon rupture and it was removed from the patient body.Therefore, the device was replaced with a new maxi ld and the procedure was completed.There was no reported patient injury.The lesion was the inferior vena cava with stenosis.A device was stored in-hospital sanitary area storage.It was opened cath room and appearance.No damage was seen on the sterilization bag.Completed device flushing and deflating.They¿ve checked the stenosis part and pre-dilation was performed with a non-cordis balloon catheter second time.Additional procedural details were requested but are unknown.The device was not returned for evaluation because it was discarded due to hospital regulation.A product history record (phr) review of lot 82177568 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon leakage - during positive pressure¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.It is likely vessel characteristics of stenosis may have contributed to the reported event as damage to balloon material may have occurred when attempting to dilate the stenosis.However, without the return of the device for analysis, it is difficult to draw a clinical conclusion between the device and the event reported.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 PTA F7 110 25X40
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CARDINAL HEALTH MEXICO; av prado sur 150 2d0 piso; ciudad de mexico 11000 ; MX 11000
• MDR Report Key: 11495912
• Report Number: 9616099-2021-04340
• Device Sequence Number: 2869961
• Product Code: LIT
• UDI-Device Identifier: 20705032002391
• UDI-Public: 20705032002391
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2021

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: 02/28/2021
• Device Model Number: 4162540L
• Device Catalogue Number: 4162540L
• Device Lot Number: 82177568
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 04/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN BALLOON CATHETER.