MAUDE Adverse Event Report: ABBOTT VASCULAR INC. VIATRAC; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	1008197-30
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a heavily tortuous left upper limb arteriovenous fistula with 60% stenosis.With access obtained in the right inguinal femoral artery, arterio venography was performed and a 6x30mm viatrac 14 plus peripheral dilatation catheter was used for dilatation.The basilic vein was visualized 5 cm proximal to the fistula, and balloon dilatation was again performed followed by an additional arterio venography which showed unobstructed blood flow.During withdrawal there was resistance and the balloon separated.Angiography confirmed the balloon was found at the distal end of the catheter sheath.Retrieval was attempted by cut down then successfully retrieved by snare.Patient had significant bleeding which was controlled by applying manual pressure.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
The device was not returned for evaluation.Production record and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed no other similar complaints from this lot.The reported patient hemorrhage/blood loss/bleeding is listed in the peripheral dilatation catheter (pdc), viatrac 14 plus, global, instruction for use (ifu) as a known patient effect.Based on the reported information and results of the complaint investigation there is no indication the reported difficulty removing the device, or a balloon separation are related to a potential product quality issue.The investigation was unable to determine a conclusive cause for the reported difficulty removing the device; however, the reported separation, unexpected medical intervention and surgical intervention appear to be related to circumstances of the procedure.A conclusive cause for the reported patient effect of hemorrhage/blood loss/bleeding and the relationship to the device, if any, cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.G2- other report source updated.
Event or Problem Description
N/a.

• Brand Name: VIATRAC
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 19828513
• Report Number: 2024168-2024-08811
• Device Sequence Number: 8891548
• Product Code: LIT
• UDI-Device Identifier: 08717648057151
• UDI-Public: (01)08717648057151(17)241031(10)2111662
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K221057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: 1008197-30
• Device Catalogue Number: 1008197-30
• Device Lot Number: 2111662
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/05/2024
• Supplement Date Received by Manufacturer: 08/02/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/16/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown