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

Model Number	1011880
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Stretched (1601); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure performed was to treat a de mildly tortuous left circumflex coronary artery that is 50% stenosed.A 0.14 hi-torque (ht) balance middleweight (bmw) elite guide wire was advanced to the lesion and an unspecified stent was implanted.Resistance was noted when attempting to remove the ht bmw elite guidewire due to anatomy and a previously deployed stent, and after multiple attempts, the guidewire's coils stretched but the core remained intact.The ht bmw elite guidewire was successfully withdrawn.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the corrective and preventive actions (capa) database was performed and revealed no indication of a product quality issue.A review of production records and the complaint handling database was not performed because the lot number was not reported.The investigation determined the reported difficulties appear to be related to the operational context of the procedure.It is likely that manipulation of the wire, when resistance was met, contributed to the reported stretched coils.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the corrective and preventive actions (capa) database was performed and revealed no indication of a product quality issue.A review of production records and the complaint handling database was not performed because the lot number was not reported.It was reported that a force was applied during use of the guide wire.It should be noted that the hi-torque guide wires for ptca, pta, stents instructions for use (ifu) states: ¿do not push, auger, withdraw, or torque a guide wire that meets excessive resistance.¿ in this case, the deviation likely did not contribute to the reported issue.The investigation determined the reported difficulties appear to be related to the operational context of the procedure.It was reported that the guide wire met resistance with the patient¿s mildly tortuous and 50% stenosed lesion and a previously implanted stent, resulting in difficulty during removal.It was reported that the coils were observed to be stretched after removal.It is likely that manipulation of the wire, when resistance was met, contributed to the reported stretched coils.There is no indication of a product quality issue with respect to manufacture, design, or labeling.G2 correction: report source: updated.
Event or Problem Description
Subsequently, after the report was filed it was noted that the guidewire broke, and the spring coil unscrewed; however, the guide wire remained connected by a spring coil.Additional force was applied when attempting to remove the guidewire with guiding catheter and balloon as one unit.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the production records and corrective or preventive actions (capa) 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 appear to be related to the operational context of the procedure.It was reported that the guide wire met resistance with the patient¿s mildly tortuous and 50% stenosed lesion and a previously implanted stent, resulting in difficulty during removal.Additionally, after removal, it was reported that the coils were observed to be stretched and the core broken.It is likely that manipulation of the wire, when resistance was met, contributed to the reported stretched coils and break.It was reported that a force was applied during use of the guide wire.It should be noted that the hi-torque guide wires for ptca, pta, stents instructions for use (ifu) states: ¿do not push, auger, withdraw, or torque a guide wire that meets excessive resistance.¿ in this case, the deviation likely did not contribute to the reported issue.There is no indication of a product quality issue with respect to manufacture, design, or labeling.H6: medical device problem code 2017 - excessive force.H6 correction: type of investigation code 4109 added.H11 correction: additional mfg narrative: updated.

• 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 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 21243933
• Report Number: 2024168-2025-00909
• Device Sequence Number: 19739773
• Product Code: DQX
• UDI-Device Identifier: 08717648144783
• UDI-Public: (01)08717648144783(11)240605(17)260531(10)4060571
• 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: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2026
• Device Model Number: 1011880
• Device Catalogue Number: 1011880
• Device Lot Number: 4060571
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/07/2025
• Supplement Date Received by Manufacturer: 04/28/2025; 05/15/2025
• Initial Report FDA Received Date: 01/27/2025
• Supplement Report FDA Received Date: 05/13/2025; 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/05/2024
• 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
• Patient Sex: Unknown