MAUDE Adverse Event Report: ABBOTT VASCULAR INC. HI-TORQUE BALANCE MIDDLEWEIGHT ELITE; WIRE, GUIDE, CATHETER

Model Number	1011880J
Medical Device Problem Codes	Break (1069); Material Separation (1562); Stretched (1601)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 the procedure was to treat a patient with ostial disease of common trunk, left anterior descending (lad), and circumflex (cx) coronary arteries.One balance middleweight elite guide wire was positioned in the lad and other in the cx in a loop.The lesion was pre-dilatated and intravascular ultrasound (ivus) found calcium present.Shockwave technique was used and a 3.5x24mm unspecified stents were implanted in the iva -trunk ostial part.Post dilatation was performed with a 3.75mm unspecified balloon.When attempting to remove the bmw that was in the cx, there was no resistance felt; however, the tip could be seen on the monitor about 1 centimeter jailed inside and outside the newly implanted stent.It was noted during removal the guide wire stretched, fractured and then fully separated at the tip.Another 2.5x12mm unspecified stent was implanted in the ostium of the cx branch to jail the tip and to treat the branch that was already sub-occluded to the ostium.There was no adverse patient sequela and no clinically significant delay reported.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported starched coils were confirmed.The reported core separation was confirmed as coil separation.The reported tip break was not confirmed.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.The investigation determined the reported difficulties and subsequent treatments appear to be related to the operational context of the procedure.In this case, it was reported that the guide wire interacted with the implanted stent during removal.It is likely that manipulation of the guide wire during its interaction with the stent, contributed to the reported stretched/damaged coils and subsequent material separations.The separated portion of the guide wire was embedded in the anatomy.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Na.
Additional Manufacturer Narrative
H2: updated the device identification fields to align with the information in the corresponding fields in gudid.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT ELITE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• 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: 17951169
• Report Number: 2024168-2023-11451
• Device Sequence Number: 7670204
• Product Code: DQX
• UDI-Device Identifier: 08717648144790
• UDI-Public: (01)08717648144790(17)250430(10)3051761
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K152709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/24/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2025
• Device Model Number: 1011880J
• Device Catalogue Number: 1011880J
• Device Lot Number: 3051761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/25/2023
• Supplement Date Received by Manufacturer: 12/05/2023; 06/13/2024
• Initial Report FDA Received Date: 10/17/2023
• Supplement Report FDA Received Date: 12/15/2023; 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 75 KG