MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE PILOT GUIDE WIRE

Model Number	1010480-H
Medical Device Problem Codes	Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The incident information was reviewed; however, the product was not returned to abbott vascular for analysis.A review of the electronic lot history record and similar incident query for this product was not performed because the lot number was not reported.The investigation determined the reported difficulties appear to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.A partial udi is being reported because the lot number was not provided.User facility /maude report number received #(b)(4).
Event or Problem Description
Describe the event or problem: patient came in as stemi (st-elevation myocardial infarction).Patient was taken to ccl (cardiac catheterization lab).A radial approach was used.Tiger catheter was used to dilate both the right and left systems.A guide which was an ali, was advanced in a similar fashion into the ostium of the rca (right coronary artery) with the help of crossfit wire as well as a pilot wire.The rca (right coronary artery) was totally occluded; it was cannulated.A balloon was advanced followed by another balloon; multiple inflations were carried out along the course of the total occlusion.At that time, it was noted that the tip of the pilot wire was broken inside the rca.Plan was to snare out the tip of the pilot wire.The snare was advanced over each delivery system and was released inside the rca.After manipulation, the tip of the wire was sucked into the delivery system of the snare and both the snare and delivery system were pulled out pulling the tip of the wire along with them.Planned procedure was completed without any further complication.No patient harm.Post procedure: patient transferred to icu pain-free and stable, patient remained stable and pain-free in icu 18 hours post-procedure.Angiographically, no wire or device left in patient.What was the original intended procedure? : left heart catheterization.Selective arteriography.Angioplasty.Stent placement in the midportion and proximal portion of rca.What problem did the user have (check all that apply) :device failed (e.G.Broke, couldn't get it to work or stopped working).

• Brand Name: HI-TORQUE PILOT GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005737652; road no.2 km 58.0 cruce dávila; barceloneta PR 00617
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 16645591
• Report Number: 2024168-2023-03245
• Device Sequence Number: 17666624
• Product Code: DQX
• UDI-Device Identifier: 08717648073854
• UDI-Public: 08717648073854
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K101116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/30/2023

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 Model Number: 1010480-H
• Device Catalogue Number: 1010480-H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: CROSSFIT GUIDE WIRE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 94 KG
• Patient Ethnicity: Hispanic
• Patient Race: White