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

Model Number	1010480-HJ
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); 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	12/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
G9: exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device will not be returned for evaluation.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 provided to treat a de novo lesion in the moderately calcified, moderately tortuous left anterior descending coronary artery.The hi torque pilot 50 guide wire faced resistance during advancement with an unspecified guiding catheter.Then the guide wire faced resistance during removal with the same guiding catheter, so force was applied.The tip separated, so a snare device was used to retrieve the separated tip.A new hi torque pilot 50 guide wire was used to successfully complete the procedure.There were no adverse patient sequelae 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.Return of the device and guide wire and guiding catheter may have further aided the analysis.It should be noted that instructions for use guide wire hi-torque guide wires, states: carefully observe the instructions under ¿do not¿ and ¿do¿ below.This nonconformance does not appear to have contributed to the reported complaint.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.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/position, difficulty to remove and tip separations appear to be related to operational circumstances of the procedure.It is likely that manipulation during advancement of the guide wire through the guiding catheter, the guide wire likely kinked resulting in the reported failure to advance and the difficulty to remove.During retraction the kink ultimately resulted in the tip separation.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: HT PILOT
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9571862
• Report Number: 2024168-2020-00521
• Device Sequence Number: 3337315
• 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): 03/11/2020

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: 01/31/2021
• Device Model Number: 1010480-HJ
• Device Catalogue Number: 1010480-HJ
• Device Lot Number: 9022671
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/16/2019
• Supplement Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 03/11/2020
• 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
• Patient Age: 60 YR
• Patient Weight: 74