MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE STEEL CORE 18 GUIDE WIRE WITH MICROGLIDE® COATING

Model Number	1003282
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown if the device is returning for analysis.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that this was a cardiomems procedure.The cardiomems sensor was advanced over the ht (hi-torque) steelcore 18 guide wire and went through the sheath and advanced a little further but the delivery system would not continue to advance.The delivery system was stuck on the guide wire.Another sheath, ht steelcore guide wire and sensor were used and the sensor was successfully deployed to complete the procedure.There was no adverse patient effect and there was no reported clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual and dimensional inspection was performed on the returned guide wire and the reported core separation was confirmed.The reported difficulty to advance and remove were unable to be confirmed due to the returned condition of the guide wire.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents reported from this lot.There was no damage noted to the guide wire during the inspection prior to use which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties.The investigation determined the reported difficulty to advance, difficulty to remove and core separation appear to be related to case circumstances of the procedure.In this case, it is likely that during advancement the guide wire became damaged resulting in the difficulty to advance and remove the cardiomems sensor device over the guide wire.Manipulation against resistance likely caused the noted damages to the sensor device and teflon coating damage on the guide wire.Per the reported information, the core separation occurred post procedure on the back table and likely due to manipulation.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that this was a cardiomems procedure.The cardiomems sensor was advanced over the ht (hi-torque) steelcore 18 guide wire and went through the sheath and advanced a little further but the delivery system would not continue to advance.The delivery system was stuck on the guide wire.Another sheath, ht steelcore guide wire and sensor were used and the sensor was successfully deployed to complete the procedure.There was no adverse patient effect and there was no reported clinically significant delay in the procedure.Subsequent to the initially filed report, the following information was provided: the procedure was in the pulmonary artery and the delivery system and the guide wire were removed together as a single unit.Returned device analysis noted that the guide wire core was separated and the separated distal portion of the guidewire was not returned.It was confirmed that the account was aware of the separation and the separation happened on the table and there was no portion of the guide wire left in the anatomy.No additional information was provided.

• Brand Name: HI-TORQUE STEEL CORE 18 GUIDE WIRE WITH MICROGLIDE® COATING
• 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: 13314848
• Report Number: 2024168-2022-00722
• Device Sequence Number: 1580086
• Product Code: DQX
• UDI-Device Identifier: 08717648013959
• UDI-Public: 08717648013959
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/15/2022

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: 09/30/2023
• Device Model Number: 1003282
• Device Catalogue Number: 1003282
• Device Lot Number: 1101561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/29/2021
• Supplement Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 01/21/2022
• Supplement Report FDA Received Date: 04/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CARDIOMEMS.
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 95 KG