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

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); Perforation of Vessels (2135)
Date of Event	01/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4: the udi is unknown because the part/lot number were not provided.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that this was a cardiomems procedure to place the cardiomems sensor.The device was deployed and the catheter was being switched out for calibration when the patient began to cough up blood.It was noted that a perforation occurred, due to the steelcore guide wire which was being used.A non-abbott catheter was advanced and inflated to treat the perforation.Angiography showed no leaks of contrast in any of the vessels.The patient was hospitalized over night for observation and then sent home the next day.No additional information was provided.
Additional Manufacturer Narrative
H6: medical device problem code 1494 - indication for use.The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A review of similar incidents is not required.Reportedly, the guide wire was used in a cardiomems procedure resulting in hemorrhage/hemoptysis.It should be noted that the hi-torque guide wires instructions for use (indications for use section) states: ¿all hi-torque guide wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (ptca) and percutaneous transluminal angioplasty (pta).¿ in this case, it is unlikely the guide wire contributed to the reported patient effect.The investigation determined the reported patient effects and subsequent treatment appear to be related to the operational context of the procedure.In this case, it was reported that the steelcore guide wire was used in a cardiomems procedure.The details of this case were examined by a medial specialist, they determined that the guide wire was likely not responsible for the reported patient effect of hemorrhage/hemoptysis.The cardiomems instructions for use (ifu) states hemoptysis is a potential adverse event associated with the implantation procedure.Additionally, the steelcore guide wire is not indicated for use in pulmonary arteries; as such, hemoptysis is not listed as a potential adverse event in the steelcore guidewire ifu.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Medical review performed stated: this was a cardiomems hf sensor implant case in a 72-year-old female patient.This was an off-label use of the steelcore guidewire used to implant the cardiomems heart failure (hf) pa sensor system.The hemoptysis was seen after the cardiomems was implanted.The cardiomems instructions for use (ifu) state that hemoptysis is a potential adverse event that was seen in multiple clinical studies.The steelcore wire is not indicated for use in the pulmonary arteries (pa); as such hemoptysis is not listed as a potential adverse event in the steelcore guidewire ifu.Additionally, it was reported that there were no issues with the steelcore guidewire during the procedure, though the physician stated that they thought the steelcore guidewire caused a perforation in the pulmonary artery.It is possible that the steelcore wire could have caused a perforation in the pulmonary artery, however, it is likely that the patient would have experienced more severe adverse events than hemoptysis if their pulmonary artery had been perforated.Several possible mechanisms can cause pa injury and cause hemoptysis in patients undergoing cardiomems implantation.The most common cause of injury is the migration of the catheter's nose cone or wire.3 in addition, pa walls of patients with hf are friable and more prone to injury due to the fragmentation of the internal elastic lamina and deposition of disorganized extracellular matrix.3 the type of wire used for selecting pulmonary arteries can have a bearing on the risk of iatrogenic injury.For example, non-abbott hydrophilic coated guidewires are notorious for causing dissections and perforations if the physician does not respond adequately to the tactile feedback during the procedure.4 due to the information provided, it can be definitively stated that the cardiomems device was the most likely cause of this patient's hemoptysis.However, though it cannot be definitively stated that the steelcore guidewire was the direct cause of the hemoptysis, it may have been a contributing factor.H6: health effect - impact code 4650 removed; 1888 added.H6: medical device problem code 2993 removed; 1494 added.

• Brand Name: HI-TORQUE STEELCORE 18 GUIDE WIRE (MDD)
• 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: 18728248
• Report Number: 2024168-2024-01954
• Device Sequence Number: 12197694
• Product Code: DQX
• UDI-Device Identifier: 08717648013959
• UDI-Public: 08717648013959
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/14/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Catalogue Number: 1003282
• Device Lot Number: 3100962
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2024
• Supplement Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 02/17/2024
• Supplement Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2023
• 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: CARDIOMEMS SENSOR AND DELIVERY SYSTEM.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 97 KG