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

Model Number	1007710
Medical Device Problem Codes	Difficult to Remove (1528); Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	10/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a cardiomems implantation procedure, the ht steelcore 18 guide wire (gw) prolapsed in the lower branch of the left pulmonary artery.Resistance was noted during removal of the wire.At some point, the patient started to cough up blood.It was thought that the wire likely caused a small perforation in the pulmonary artery at the time of removal.Heparin reversal was administered and the patient was suctioned until the blood began to clot.The patient was transferred to the intensive care unit, then the step down unit for monitoring overnight.There was no reported adverse patient sequela.No additional information was provided.
Additional Manufacturer Narrative
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.Additionally, a review of the complaint history identified no other incidents/complaints from this lot.A conclusive cause for the reported difficulties and patient effect, 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.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: HI-TORQUE STEELCORE 18 LT 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: 15712550
• Report Number: 2024168-2022-11177
• Device Sequence Number: 12005140
• Product Code: DQX
• UDI-Device Identifier: 08717648014123
• UDI-Public: 08717648014123
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• Report Date (Section B): 11/01/2022

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: 05/31/2024
• Device Model Number: 1007710
• Device Catalogue Number: 1007710
• Device Lot Number: 2060861
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2022
• Initial Report FDA Received Date: 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2022
• 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; Hospitalization
• Patient Sex: Female
• Patient Weight: 62 KG