MAUDE Adverse Event Report: ABBOTT VASCULAR HT PILOT; GUIDE WIRE

Model Number	1010480-HJ
Medical Device Problem Codes	Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2019001.(b)(4).The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was performed to treat a moderately calcified, moderately tortuous de novo left anterior descending artery.The pilot 50 guide wire met resistance with an unspecified balloon catheter.Resistance was also noted during retrieval and force was applied.Although it was reported that during use, the polymer coating peeled off of the guide wire and was retrieved with the balloon catheter as a single unit, the image provided shows the separated [polymer coating] is a clear tubing which is not a component of the pilot 50 guide wire.A new unspecified guide wire was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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 incidents 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.It should be noted that instructions for use guide wire hi-torque guide wires ce fda states: if resistance is observed at any time, determine the cause under fluoroscopy and take remedial action as needed.Do not push, auger, withdraw or torque a guide wire that meets resistance.The investigation determined the reported difficulties appear to be related to operational circumstances of the procedure.It is likely that during advancement of the balloon catheter over the guide wire and through the anatomy, the balloon catheter encountered resistance with the moderately calcified, moderately tortuous causing interaction issues between the guide wire and balloon catheter.Inadvertent mishandling and/or manipulation likely caused damage to the balloon catheter resulting in the reported difficulty to remove.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: HT PILOT
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9511241
• Report Number: 2024168-2019-14924
• Device Sequence Number: 18923917
• Product Code: DQX
• UDI-Device Identifier: 08717648073861
• UDI-Public: 08717648073861
• Combination Product (Y/N): N
• Initial Reporter Country: IR
• PMA/510(K) Number: K101116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2020

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: 12/31/2020
• Device Model Number: 1010480-HJ
• Device Catalogue Number: 1010480-HJ
• Device Lot Number: 9012871
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 02/01/2020
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 02/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 74