MAUDE Adverse Event Report: ABBOTT VASCULAR ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATI

Model Number	1001782J-HC
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/29/2020
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.The additional xience alpine device referenced is filed under a separate medwatch report number.Na.
Event or Problem Description
It was reported that the procedure was treat a left anterior descending artery.A 2.5x28mm xience alpine was attempted to advance over the 014 balance middleweight hydro guide wire; however, it became stuck.Both devices were simply removed as one unit.Another unspecified stent and guide wire were used to successfully complete the procedure.There was no adverse patient effects and no clinically significant delay.No additional information was provided.
Event or Problem Description
It was reported that the procedure was treat a left anterior descending artery.A 2.5x28mm xience alpine was attempted to advance over the.014 balance middleweight hydro guide wire; however, it became stuck.Both devices were simply removed as one unit.Another unspecified stent and guide wire were used to successfully complete the procedure.There was no adverse patient effects and no clinically significant delay.Subsequent to filing the initial report, the following clarification was received: the 2.5x28mm xience alpine was the device used to successfully complete the procedure and not the device that became stuck on the bmw guide wire.The device that became stuck on the bmw guide wire was a non-abbott stent.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed and the reported difficulty to advance and remove were confirmed as the guide wire was returned frozen in the sds guide wire lumen.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.Factors that may contribute to the difficulty to advance/position the guide wire and cause resistance between the devices may include, but not limited to, manufacturing, device placement technique, guiding catheter support, anatomical conditions, inner diameter of guide wire lumen or delivery device, outer diameter of the guide wire, condition of the guide wire, condition of the sds, condition of the guide wire lumen, coagulation of blood or procedural contaminates.The investigation was unable to determine a conclusive cause for the reported difficult to advance/position and difficulty to remove the stent delivery system (sds) over the guide wire.The noted bends on the core and offset coils likely occurred during packing for return analysis.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.B5: additional information added.D10: boston scientific synergy stent added.The 2.5x28mm xience alpine stent removed.

• Brand Name: ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATI
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11179593
• Report Number: 2024168-2021-00491
• Device Sequence Number: 2994509
• Product Code: DQX
• UDI-Device Identifier: 08717648026010
• UDI-Public: 08717648026010
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K021228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2021

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: 09/30/2022
• Device Model Number: 1001782J-HC
• Device Catalogue Number: 1001782J-HC
• Device Lot Number: 0100171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Initial Date Received by Manufacturer: 12/29/2020
• Supplement Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 01/15/2021
• Supplement Report FDA Received Date: 02/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.5X28MM XIENCE ALPINE.; BOSTON SCIENTIFIC SYNERGY STENT.