MAUDE Adverse Event Report: ABBOTT VASCULAR HT VERSATURN GUIDE WIRE

Catalog Number	1013319
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135); Cardiac Tamponade (2226)
Date of Event	07/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient id: (b)(6).It was reported that on (b)(6) 2023, at the end of percutaneous coronary interventional procedure in the mid left main, mid left anterior descending (lad), and proximal circumflex coronary artery using the versaturn guide wire, there was evidence of a small apical lad wire perforation with a small amount of staining of the myocardium.The patient was hypotensive post-procedure.Patient was given intravenous fluids, epinephrine, and dopamine.A limited echocardiogram showed pericardial effusion.Cardiac tamponade was diagnosed.Pericardiocentesis was performed with removal of 500 ml sanguinous fluid.The patient continued to be hypotensive and an additional 200 ml sanguinous fluid was removed.Patient was transfused with one unit packed red blood cells (prbc).Patient underwent a repeat coronary angiogram to assess perforation, which revealed the area had improved.He was given an additional two units prbcs.On (b)(6) 2023, echocardiogram and labs were stable.No additional fluid was removed from the pericardial drain and the condition resolved.No additional information was provided.
Additional Manufacturer Narrative
Product performance engineering reviewed the incident information; however, the product was not returned to abbott vascular for analysis.A review of the electronic lot history record and similar incident query was not performed because the lot number was not provided.The reported patient effect of perforation of vessels is listed in the hi-torque guide wires instruction for use as a known patient effect of coronary stenting procedures.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.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: HT VERSATURN 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: 17603371
• Report Number: 2024168-2023-09174
• Device Sequence Number: 6283936
• Product Code: DQX
• UDI-Device Identifier: 08717648198458
• UDI-Public: 08717648198458
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K141782
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/23/2023

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: 1013319
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2023
• Initial Report FDA Received Date: 08/23/2023
• 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
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 98 KG