MAUDE Adverse Event Report: ABBOTT VASCULAR HT VERSATURN GUIDE WIRE

Model Number	1013319
Medical Device Problem Codes	Peeled/Delaminated (1454); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Pericardial Effusion (3271)
Date of Event	12/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 to treat a heavily calcified, heavily tortuous lesion in the circumflex (cx) artery.The ht versaturn guide wire (gw) was positioned together with a non-abbott guide wire, but the versa turn gw became prolapsed.During removal of the versaturn guide wire, resistance was met and the gw became kinked and delaminated.A coronary perforation with pericardial effusion occurred.The patient was treated with medication and a stent was implanted to complete the procedure.There was no adverse patient sequela.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 (ifu) hi-torque guide wire, states: carefully observe the instructions under ¿do not¿ and ¿do¿ below.Failure to do so may result in vessel trauma, guide wire damage, guide wire tip separation, or stent damage.If resistance is observed at any time, determine the cause under fluoroscopy and take remedial action as needed.Use the most suitable guide wire for the lesion being treated.Do not allow the guide wire tip to remain in a prolapsed condition.In this case, the prolapsed technique of positioning the guide wire does appear to have caused or contributed to the reported difficulties.The reported patient effect of perforation is listed in ifu as a known patient effects of the procedure.The investigation determined the reported difficulties and subsequent perforation and pericardial effusion appear to be related to user error.In this case, the prolapsed technique of positioning the guide wire appears to have caused the guide wire to kink and appear peeled/delaminated resulting in the difficulty to remove.Manipulation of the prolapsed guide wire likely resulting in the reported perforation and pericardial effusion.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 13172550
• Report Number: 2024168-2022-00116
• Device Sequence Number: 14647627
• 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): 02/14/2022

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: 09/30/2023
• Device Model Number: 1013319
• Device Catalogue Number: 1013319
• Device Lot Number: 1102271
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/16/2021
• Supplement Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 02/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CHOICE GUIDE WIRE
• Outcome Attributed to Adverse Event: Other; Other
• Patient Sex: Unknown