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

Model Number	1009666
Medical Device Problem Codes	Break (1069); Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that when purging the balance middleweight (bmw) universal ii guide wire before use, the proximal portion was noted to be broken but still held together by coils.The device was not used and there was no patient involvement.A new bmw guide wire was used to complete the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported break on the proximal portion was not confirmed.The reported stretched coils was confirmed and likely interpreted as a break.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 similar incidents reported from this lot.The investigation determined the reported difficulties appears to be related to operational circumstances of the procedure.Based on the reported information and returned analysis, it is likely that inadvertent mishandling of the guide wire during preparation caused the reported stretch and the appearance of a break.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11255194
• Report Number: 2024168-2021-00747
• Device Sequence Number: 17013862
• Product Code: DQX
• UDI-Device Identifier: 08717648118739
• UDI-Public: 08717648118739
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K072460
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 1009666
• Device Catalogue Number: 1009666
• Device Lot Number: 0073171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Initial Date Received by Manufacturer: 01/13/2021
• Supplement Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 01/29/2021
• Supplement Report FDA Received Date: 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1