MAUDE Adverse Event Report: ABBOTT VASCULAR HT BALANCE GUIDE WIRE

Model Number	1001782-HC
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 similar 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 tip separation appears to be related to operational circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat the right femoral vein.The balance middle weight hydro guide wire was advanced without issue to the lesion.It was decided to perform a sheath exchange as the physician was unsatisfied with the current sheath.While performing the sheath exchange, the distal tip of the guide wire broke in two pieces.A snare device was used to retrieve the free-floating tip.There was no adverse patient sequela and no clinically significant delay.No additional information was provided.

• Brand Name: HT BALANCE GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10440521
• Report Number: 2024168-2020-07028
• Device Sequence Number: 11467170
• Product Code: DQX
• UDI-Device Identifier: 08717648025990
• UDI-Public: 08717648025990
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K021228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/22/2020

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: 04/30/2022
• Device Model Number: 1001782-HC
• Device Catalogue Number: 1001782-HC
• Device Lot Number: 0052671
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 08/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention