MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE PILOT GUIDE WIRE

Model Number	1010480-HJ
Medical Device Problem Codes	Difficult to Advance (2920); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual, dimensional, and functional inspection was performed on the returned guide wire which identified the proximal end of the polymer coating was torn.Although some resistance was noted during functional testing, the resistance was likely due to the core damages.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.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/patient anatomical morphology, inner diameter of guide wire lumen or delivery device, outer diameter of the guide wire, condition of the guide wire, condition of the delivery device, coagulation of blood or procedural contaminates.The investigation was unable to determine a conclusive cause for the reported difficulty to advance through a balloon dilatation catheter (bdc) and stent delivery system (sds).In this case, it is possible that heavily tortuous anatomy reduced the clearance on the guide wire lumen resulting in the difficulty to advance over the guide wire during the procedure; however, this could not be confirmed.The noted kinks and bends and core likely occurred during packing for return analysis and likely what caused the noted resistance during functional testing.It should be noted that kinks and bend were not reported by the account.The noted teflon and polymer coating damages likely occurred during retraction through the torque device and/or other accessory devices used in 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 a heavily tortuous vessel in the left coronary artery (lca).The hi-torque (ht) pilot and (2) balance middleweight (bmw) universal ii guide wires were attempted to be used, however, stents and balloons were difficult to advance over the guide wires.The stent delivery system (sds) and balloon dilatation catheter (bdc) were prepared and flushed prior to use.It was also noted that a third bmw guide wire was involved in the procedure.There was no adverse patient effect and there was no clinically significant delay in the procedure.Returned device analysis showed that the proximal end of the polymer coating was scratched and torn off for approximately 1.5-mm and was not returned.Communication with the account confirmed there was no material left in the patient.No additional information was provided.

• Brand Name: HI-TORQUE PILOT GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005737652; road no.2 km 58.0 cruce dávila; barceloneta PR 00617
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 13666817
• Report Number: 2024168-2022-02232
• Device Sequence Number: 5474856
• Product Code: DQX
• UDI-Device Identifier: 08717648073861
• UDI-Public: 08717648073861
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K101116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/04/2022

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: 04/30/2023
• Device Model Number: 1010480-HJ
• Device Catalogue Number: 1010480-HJ
• Device Lot Number: 1051071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2022
• Initial Report FDA Received Date: 03/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown