MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE STEELCORE 18 GUIDE WIRE

Catalog Number	1003282
Medical Device Problem Codes	Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Perforation of Vessels (2135)
Date of Event	06/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.D4- the udi number is not known as the catalogue number was not provided.H6- device code 1494 clarifier: incorrect anatomy.
Event or Problem Description
It was reported that the procedure was to treat an unspecified lesion in the pulmonary artery.After a cardiomems sensor was implanted, the steelcore 18 guide wire (gw) was being pulled back when the patient experienced hemoptysis or coughing up blood.No treatment was provided for the bleeding as it resolved on its own.The patient was intubated overnight for observation.The patient had really high pulmonary artery and blood pressures during the procedure.Medications were given to keep the patient sedated.The patient is currently stable and not intubated.The physician stated he believes the.018 steelcore gw perforated the pulmonary artery.The patient had not been discharged as of (b)(6) 2023.No additional information was provided.
Additional Manufacturer Narrative
The incident information was reviewed; however, the product was not returned for analysis.A review of the electronic lot history record, corrective action tracking system for the web database review, and similar incident query was not performed because the lot numbers were not reported.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined; however, the subsequent treatments appear to be related to the operational context of the procedure.Reportedly, the guide wire was used in a pulmonary artery procedure.It should be noted that the hi-torque guide wires instructions for use (ifu) states: ¿all hi-torque guide wire are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (ptca) and percutaneous transluminal angioplasty (pta).This guide wire may also be used with compatible stent devices during therapeutic procedures.¿ in this case, the deviation possibly contributed to the reported event.The reported patient effect of performation is listed in the hi-torque guide wires ifu as a known patient effect of coronary stenting procedures.There is no indication of a product quality issue with respect to manufacture, design, or labeling; therefore, no product-related corrective action will be implemented in this case.

• Brand Name: HI-TORQUE STEELCORE 18 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 # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 17221017
• Report Number: 2024168-2023-06918
• Device Sequence Number: 16899947
• Product Code: DQX
• UDI-Device Identifier: 08717648013959
• UDI-Public: 08717648013959
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K982876
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2023

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 1003282
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2023
• Supplement Date Received by Manufacturer: 06/30/2023
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 07/25/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 120 KG