MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO 244 S DE RL DE CV SABER 4MM20CM 150 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	N/A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Telephone number is (b)(6).Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
A 4mm20cm 150 saber percutaneous transluminal angioplasty (pta) balloon catheter was used to treat the inferior genicular (popliteal) artery but "after the balloon was opened, it could not be fully retracted, and the blood vessel was directly withdrawn without secondary expansion." the device was used inside the patient.There was no reported patient injury.The device will be returned for analysis.
Additional Manufacturer Narrative
A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
A 4mm x 20cm 150 saber percutaneous transluminal angioplasty (pta) balloon catheter was used to treat the inferior genicular (popliteal) artery but "after the balloon was opened, it could not be fully retracted, and the blood vessel was directly withdrawn without secondary expansion." the device was used inside the patient.There was no reported patient injury.The product was not returned for analysis.A product history record (phr) review of lot 82215051 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon withdrawal difficulty¿ could not be confirmed as the device was not returned for analysis.The exact cause cannot be determined.It is likely vessel characteristics, procedural factors and/or handling of the device may have contributed to the events reported by the customer.However, without the return of the product for analysis and with the limited amount of information provided, it is difficult to draw a clinical conclusion between the device and the reported events.According to the safety information of the instructions for use ¿prior to angioplasty, the catheter should be examined to verify functionality and integrity, and ensure that its size and shape are suitable for the specific procedure for which it is to be used.Do not use if product damage is suspected or evident.To reduce the potential for vessel damage or the risk of dislodgement of particles it is very important that the inflated diameter of the balloon should approximate the diameter of the vessel just proximal and distal to the lesion.If resistance is felt upon removal, then the balloon, guidewire and the sheath should be removed together as a unit, particularly if balloon rupture or leakage is known or suspected.Proper functioning of the catheter depends on its integrity.Care should be used when handling the catheter.Damage may result from kinking, stretching, or forceful wiping of the catheter.Forceful handling can result in catheter separation and the subsequent need to use a snare or other medical interventional techniques to retrieve the pieces.Always verify integrity of the catheter after removal.Deflate the balloon by pulling vacuum on the inflation syringe or inflation device.Apply negative pressures to the balloon for about 30 - 85 seconds until the balloon is deflated.Remove the vacuum (do not apply pressure) and carefully withdraw and remove the catheter.¿ 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: SABER 4MM20CM 150 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CARDINAL HEALTH MEXICO 244 S DE RL DE CV; santiago troncoso 808; juarez 32574 ; MX 32574
• Manufacturer (Section G): CARDINAL HEALTH MEXICO 244 S DE RL DE CV; santiago troncoso 808; juarez 32574 ; MX 32574
• Manufacturer Contact: karla castro ; 14201 nw 60th ave,; miami lakes, FL 32574 ; 7863138372
• MDR Report Key: 12673372
• Report Number: 9616099-2021-04969
• Device Sequence Number: 4852295
• Product Code: LIT
• UDI-Device Identifier: 20705032069493
• UDI-Public: 20705032069493
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K971010
• 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): 11/17/2021

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: 02/29/2024
• Device Model Number: N/A
• Device Catalogue Number: 48004020X
• Device Lot Number: 82215051
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/29/2021
• Supplement Date Received by Manufacturer: 11/02/2021; 11/17/2021
• Initial Report FDA Received Date: 10/21/2021
• Supplement Report FDA Received Date: 11/03/2021; 11/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2021
• 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
• Patient Sex: Unknown