MAUDE Adverse Event Report: ABBOTT VASCULAR INC. HI-TORQUE WHISPER¿ EXTRA SUPPORT Guide Wire with Hydrophilic Coating; Wire, Guide, Catheter

Model Number	1011834H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure performed was a pulmonary valve perforation followed by pulmonary valvuloplasty.The 014 ht whisper guide wire was positioned in the distal branch of the pulmonary artery.The guide wire was rotated clockwise to achieve and maintain stability.The guide wire was subsequently untwisted by counterclockwise rotation for removal.During advancement of the microcatheter over the guide wire, the guide wire tip detached and was retained within a distal branch of the right pulmonary artery.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database identified no other incidents from this lot.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that inadvertent interaction with the anatomy as the guide wire was rotated clockwise then upon removal untwisted counter-clockwise resulted in compromising the device such that as the micro catheter was being advanced over the wire further interaction resulted in the reported tip material separation.As reported, the wire tip was retained in the distal branch of the right pulmonary artery.Based on the reported information and results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: HI-TORQUE WHISPER¿ EXTRA SUPPORT Guide Wire with Hydrophilic Coating
• Common Device Name: Wire, Guide, Catheter
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 -280
• 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--462 ; +1(951)914-5259
• MDR Report Key: 50502968
• Report Number: 2024168-2026-03371
• Device Sequence Number: 10211556
• Product Code: DQX
• UDI-Device Identifier: 08717648116100
• UDI-Public: (01)08717648116100(17)280430(10)6051973
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K101116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/28/2026

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 Model Number: 1011834H
• Device Catalogue Number: 1011834H
• Device Lot Number: 6051973
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2026
• Initial Report FDA Received Date: 08/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/19/2026
• 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