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

Model Number	1005357H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Perforation (2001)
Date of Event	12/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no reported device malfunction and the product was not returned.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effect of perforation is listed in the instructions for use for hi-torque guide wires, ce/fda as a known patient effect of the procedure.A conclusive cause for the reported patient effects and the relationship to the product, if any, cannot be determined.Additionally, the reported treatments appear to be related to circumstances of the procedure.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 the procedure was performed to treat a lesion in the moderately calcified, moderately tortuous, 90% stenosed distal left anterior descending coronary artery.A whisper ms guide wire crossed the lesion, a 2x15mm trek balloon was used for pre-dilatation, and a 2.25x23mm xience sierra stent was implanted without issue.As an unspecified pressure wire was advanced, the whisper guide wire may have accidentally advanced and perforated the vessel, so medication was used as treatment.The patient's blood pressure decreased, so pericardiocentesis and an intra-aortic balloon pump were used.The patient went into cardiac arrest and expired that same day(b)(6) 2020.In the opinion of the physician, the use of these abbott devices did not cause or contribute to the patient death in any way.There was no clinically significant delay in the procedure.In the opinion of the physician, the use of these devices did not cause or contribute to complications or adverse events.No additional information was provided.

• Brand Name: HI-TORQUE WHISPER MS GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11167256
• Report Number: 2024168-2021-00421
• Device Sequence Number: 3718196
• Product Code: DQX
• UDI-Device Identifier: 08717648037801
• UDI-Public: 08717648037801
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/13/2021

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: 06/30/2022
• Device Model Number: 1005357H
• Device Catalogue Number: 1005357H
• Device Lot Number: 0071671
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2020
• Initial Report FDA Received Date: 01/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Weight: 55