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

Model Number	1001780
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat an unspecified lesion in a coronary artery.During placement of a radial introducer sheath on the balance middleweight (bmw) guide wire, there was a separation of the guide wire.There was resistance during removal with the guiding catheter and force was applied.A 30 cm fragment remained in the artery and was removed with a lasso via the femoral route.There were no adverse patient sequela.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6: device code 2017- excessive force.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported material separation was confirmed.The reported difficult to remove could not be tested as it was based on operational context.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.It was reported that during placement of the guide wire, a separation occurred.Analysis of the returned wire confirmed the separation, located at the proximal end of the hypotube.The separation face was bent and jagged.This type of damage is consistent with manipulation of the wire, at a kink or bend.Additionally, the analysis noted misaligned coils and bends on the shaping ribbon.This type of damage can occur due to interaction with the anatomy, or an accessory device.Misaligned coils could contribute to reduced clearance with the guide catheter, possible contributing to the reported resistance during removal.Additionally, it was reported that the separated portion of the guide wire was removed via a lasso.It was reported that a force was applied during removal of the guide wire.It should be noted that the hi-torque guide wires for ptca, pta, stents instructions for use (section warnings) states: ¿do not push, auger, withdraw, or torque a guide wire that meets excessive resistance.¿ in this case, the deviation appears to be a reasonable clinical response.In this case, 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.

• 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: 20559313
• Report Number: 2024168-2024-12670
• Device Sequence Number: 14253181
• Product Code: DQX
• UDI-Device Identifier: 08717648013836
• UDI-Public: (01)08717648013836(17)250630(10)3072071
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2024

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: 06/30/2025
• Device Model Number: 1001780
• Device Catalogue Number: 1001780
• Device Lot Number: 3072071
• 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: 10/07/2024
• Supplement Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED GUIDING CATHETER.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown