MAUDE Adverse Event Report: ABBOTT VASCULAR HT VERSATURN GUIDE WIRE

Model Number	1013319
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Stretched (1601); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned 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 of the reported lot did not indicate a lot specific quality issue.The investigation was unable to determine a conclusive cause for the reported difficulties.Factors that may contribute to difficulty advancing and removing the guide wire through the guide catheter include, but are not limited to, inner diameter of the guide catheter, outer diameter of the guide wire, buildup of procedural contaminants in the guide catheter, and/or damage to the guide catheter or guide wire.Factors that may contribute to material separation (tip) during use include, but are not limited to, interaction with patient anatomy, interaction with an accessory device, corrosion, and/or material properties.In this case, it is possible that the guide wire experienced reduced clearance with the guide catheter due to procedural contaminants or tortuous anatomy during advancement, as resistance was noted, resulting in the reported difficult to advance.Manipulation of the guide wire when met with resistance possible resulted in the reported material separation (tip).Additionally, damage to the guide wire (separated tip) possibly contributed to the reported difficult to remove; however, this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the proximal left anterior descending (plad) artery.The 014 ht versaturn f 190 guide wire (gw) was advanced to the target lesion; however, difficulty was noted with the guide catheter (gc).When a stent was placed on the gw for advancement the physician noted that the gw tip broke in 2 pieces.Therefore, the gw was removed from the patient and difficulty was noted during removal with the gc.A small amount of force had to be applied to remove the gw.There was no adverse patient effect and no clinically significant delay reported in to the procedure.A non-abbott gw was used to continue the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual and dimensional inspection was performed on the returned device.The reported stretched coils were confirmed.The reported difficult to advance and difficult to remove could not be tested as it was based on operational context.The investigation was unable to determine a conclusive cause for the reported difficulties.Factors that may contribute to difficulty advancing and removing the guide wire through the guide catheter include, but are not limited to, inner diameter of the guide catheter, outer diameter of the guide wire, buildup of procedural contaminants in the guide catheter, and/or damage to the guide catheter or guide wire.Factors that may contribute to stretched coils during use include, but are not limited to, interaction with patient anatomy, interaction with an accessory device, and/or material properties.In this case, it is possible that the guide wire experienced reduced clearance with the guide catheter due to procedural contaminants or tortuous anatomy during advancement, as resistance was noted, resulting in the reported difficult to advance.Manipulation of the guide wire when met with resistance possibly resulted in the reported stretched coils.Damage to the guide wire (stretched coils) possibly contributed to the reported difficult to remove; however, this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design, or labeling.B5 - describe event or problem.D9, h3 - device available for evaluation.H6 - medical device problem code 1562 - removed.H6 - type of investigation code 4114 - removed.
Event or Problem Description
Subsequent to the previously filed report, return device analysis found the guide wire coils were stretched distally; thus, the tip appeared wavy, but was not separated into 2 pieces.The account confirmed that the correct device was returned and that the reported tip break was actually stretched coils.No additional information was provided.

• Brand Name: HT VERSATURN 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: 16373543
• Report Number: 2024168-2023-01483
• Device Sequence Number: 6748853
• Product Code: DQX
• UDI-Device Identifier: 08717648198458
• UDI-Public: 08717648198458
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K141782
• 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,Followup
• Report Date (Section B): 06/01/2023

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: 01/31/2024
• Device Model Number: 1013319
• Device Catalogue Number: 1013319
• Device Lot Number: 2022671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2023
• Supplement Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 02/14/2023
• Supplement Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2022
• 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 Age: 62 YR
• Patient Sex: Male