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

Model Number	1001780-HC
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Stretched (1601); Difficult to Advance (2920)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	07/31/2024
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 the right coronary artery (rca).The balance middleweight (bmw) hydro guide wire was used in the procedure and when it was passed through the middle segment of the rca, the guide wire became broken but held together by stretched coils.The wire was caught with the calcified anatomy during advancement and removal.The guide wire was withdrawn independently and type a dissection shadows were seen in the proximal and middle segments of the rca.Another bmw guide wire was used to pass through the distal segment of the rca and complete the procedure.There was no treatment for the dissection and there were no adverse patient sequela.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the production records and the corrective and preventive actions (capa) database was performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed no indication of a lot specific issue.The investigation determined the reported difficulties and subsequent treatment appear to be related to the operational context of the procedure; however, a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.It was reported that the guide wire met resistance with the patient¿s calcified lesion, resulting in the reported difficulty during advancement and removal.Additionally, it was reported that the core broke and the coils stretched during the procedure.It is likely that manipulation of the wire, when resistance was met, contributed to the core break and subsequent stretched coils.The reported patient effect of dissection is listed in the hi-torque guide wires instruction for use as a known patient effect of coronary procedures.There is no indication of a product quality issue with respect to manufacture, design, or labeling; therefore, no product-related corrective action will be implemented in this case.
Event or Problem Description
It was reported that the procedure was to treat the right coronary artery (rca).The balance middleweight (bmw) hydro guide wire was used in the procedure and when it was passed through the middle segment of the rca, the guide wire became broken but held together by stretched coils.The wire was caught with the calcified anatomy during advancement and removal.The guide wire was withdrawn independently and type a dissection shadows were seen in the proximal and middle segments of the rca.Another bmw guide wire was used to pass through the distal segment of the rca and complete the procedure.There was no treatment for the dissection and there were no adverse patient sequela.No additional information was provided.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT
• 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 # 3005737652; road no.2 km 58.0 cruce dávila; barceloneta PR 00617
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 20947834
• Report Number: 2024168-2024-14830
• Device Sequence Number: 8280044
• Product Code: DQX
• UDI-Device Identifier: 08717648025969
• UDI-Public: (01)08717648025969(17)251031(10)3112072
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 01/13/2025

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: 10/31/2025
• Device Model Number: 1001780-HC
• Device Catalogue Number: 1001780-HC
• Device Lot Number: 3112072
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2024
• Supplement Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 12/16/2024
• Supplement Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/20/2023
• 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: Other
• Patient Sex: Unknown