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

Model Number	1009664J
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Stretched (1601)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/12/2024
Type of Reportable Event	Serious Injury
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, patient effect, and treatment appear to be related to the operational context of the procedure.It was reported that the guide wire interacted with an implanted stent, resulting in resistance during removal of the wire.Additionally, it is likely that manipulation of the wire, when resistance was encountered, resulted in the tip separating.The separated portion of the wire was embedded into a vessel using a stent.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported the procedure was to treat a lesion in the left anterior descending (lad) artery.Post stent implantation, the ht bmw universal ii guide wire became caught in the implanted stent and was hard to remove.The tip of the guide wire broke off; therefore, a stent was implanted to embed the separated guide wire tip.There was no adverse patient sequela.No additional information was provided.
Event or Problem Description
Subsequent to the initial report being filed.A medwatch report was received stating the following: "the bmw universal ii wire was being used for an intervention.When the physician tried removing the wire, the tip became entangled in the stent struts.After many attempts at getting this wire lose, it frayed, and the tip detached from the remaining wire.The physician was not able to retrieve the wire tip out of the artery.To prevent any complications, he secured it in place by pinning it against two deployed stents." 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, patient effect, and treatment appear to be related to the operational context of the procedure.It was reported that the guide wire interacted with an implanted stent, resulting in resistance during removal of the wire.Additionally, it is likely that manipulation of the wire, when resistance was encountered, resulted in the tip separating and stretching.The separated portion of the wire was embedded into a vessel using a stent.There is no indication of a product quality issue with respect to manufacture, design, or labeling.E4 - initial report sent to fda updated from no to yes.G2 - report source updated.H10 - related report number added.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II
• 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: 20112651
• Report Number: 2024168-2024-10346
• Device Sequence Number: 7447185
• Product Code: DQX
• UDI-Device Identifier: 08717648118753
• UDI-Public: (01)08717648118753(17)241130(10)2121271
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2024

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: 11/30/2024
• Device Model Number: 1009664J
• Device Catalogue Number: 1009664J
• Device Lot Number: 2121271
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2024
• Supplement Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 08/30/2024
• Supplement Report FDA Received Date: 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2022
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 85 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White