MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

Catalog Number UNK UNIVERSAL BMW II

Device Problems Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Device Damaged by Another Device (2915)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/01/2024

Event Type  Injury  

Event Description

It was reported that the procedure was to treat the calcified left anterior descending (lad) coronary artery.During use, the balance middleweight universal ii guide wire was advanced to the lesion without resistance.An unspecified stent was implanted in another branch and jailed the guide wire.There was resistance during removal and force was applied.The guide wire tip separated and was attempted to be removed by snare but was unsuccessful.The tip remains free floating in the patient.There were no adverse patient sequela.No additional information was provided.

Manufacturer Narrative

B3: date of event estimated d4: the udi is unknown because the part/lot number were not provided.H6: medical device problem code 2017 - excessive force h6: medical device problem code 2017 - failure to follow steps / instructions manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Manufacturer Narrative

B3: date of event updated from 2/1/2024 to 2/5/2024.B6: relevant test/laboratory data updated from 2/1/2024 to 2/5/2024.D4: lot number updated from unknown to 3030871.A visual inspection of the returned device was performed.The reported material separation was confirmed.The reported difficult to remove could not be tested due to the device condition.The reported device damaged by another device could not be tested as it was based on operational context.A review of the corrective and preventive actions (capa) database was performed and revealed no related complaint assessment capas.The electronic lot history record (elhr) identified no associated manufacturing nonconformities issued to the reported lot.Additionally, a query of the complaint handling database for the reported lot revealed no indication of a lot specific issue.It was reported that a stent was implanted in a way, such that, the guide wire became jailed.It should be noted that the hi-torque balance middleweight universal ii instructions for use, states: ¿do not: deploy a stent such that it will entrap the wire between the vessel wall and the stent.¿ in this case, it is likely that the reported issues of difficulty during removal, material separation, and guide wire damage, were a result of the guide wire being jailed and subsequent manipulation used to remove the wire.Additionally, it was noted that the separated guide wire tip remains free floating in the patient¿s anatomy.It was reported that when resistance was encountered, excessive force was applied to the wire.It should be noted that the hi-torque balance middleweight universal ii instructions for use, states: ¿do not: push, auger, withdraw, or torque a guide wire that meets resistance.¿ in this case, it was noted that the guide wire was jailed; therefore, the deviation appears to be a reasonable clinical response to the difficulty.The investigation determined the reported difficulties, patient effect, and treatment appear to be related to user error.It was reported that a stent was implanted in a way, such that, the guide wire became jailed.It should be noted that the hi-torque balance middleweight universal ii instructions for use states: ¿do not: deploy a stent such that it will entrap the wire between the vessel wall and the stent.¿ in this case, it is likely that the reported issues of difficulty during removal, material separation, and guide wire damage, were a result of the guide wire being jailed and subsequent manipulation used to remove the wire.Additionally, it was noted that the separated guide wire tip remains free floating in the patient¿s anatomy.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE
• Type of Device: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• 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: 18888078
• MDR Text Key: 337468952
• Report Number: 2024168-2024-03218
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K072460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK UNIVERSAL BMW II
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention