MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE WHISPER LS GUIDE WIRE

Model Number	1005351HJ
Medical Device Problem Codes	Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product performance engineering reviewed the incident information; however, the product was not returned to abbott vascular for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents and/or complaints reported from this lot.There was no damage noted to the guide wire during the inspection prior to use which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties.The investigation determined the reported difficulty to advance and tip separation appear to be related to case circumstances of the procedure.In this case, based on the reported information, during advancement the guide wire encountered resistance with the kidney stoned likely causing the damage to the tip ultimately separating while in the anatomy.The separated tip was retrieved via snare.There is no indication of a product quality issue with respect to manufacture, design, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat the patient's kidney.The whisper guide wire was advanced to the lesion when it met resistance with kidney stones and the tip broke off.The patient was already scheduled to have surgery for kidney stones the next day so the separated tip was retrieved via snare during that procedure.There was no adverse patient sequela and no clinically significant delay.No additional information was provided.

• Brand Name: HI-TORQUE WHISPER LS GUIDE WIRE
• Common Device Name: 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: 14226009
• Report Number: 2024168-2022-04593
• Device Sequence Number: 14505116
• Product Code: DQX
• UDI-Device Identifier: 08717648037757
• UDI-Public: 08717648037757
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 04/27/2022

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: 01/31/2023
• Device Model Number: 1005351HJ
• Device Catalogue Number: 1005351HJ
• Device Lot Number: 1021871
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2022
• Initial Report FDA Received Date: 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2021
• 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 Sex: Unknown