MAUDE Adverse Event Report: ABBOTT VASCULAR HT VERSATURN GUIDE WIRE

Catalog Number	1013319J
Medical Device Problem Codes	Peeled/Delaminated (1454); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a lesion in an unspecified artery.The versaturn guidewire(b)(4) (gw) was attempted to be used in a procedure; however, the gw met with resistance with the catheter.Therefore, the gw was removed from the patient and delamination [peeling] was noted on the gw.Another gw was used to continue the procedure.There was no adverse patient effect and no clinically significant delay reported in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The incident information was reviewed; however, the product was not returned to abbott vascular for analysis.A review of the electronic lot history record and similar incident query for this product was not performed because the part/lot numbers were not reported.The investigation was unable to determine a conclusive cause for the reported difficulties.There is no indication of a product quality issue with respect to manufacture, design, or labeling.D4: the udi is unknown due to the part/lot number was not provided.
Additional Manufacturer Narrative
A visual and dimensional inspection was performed on the returned device.The core was separated distal to the center solder, but the guide wire remained in one piece.The reported peeled/delaminated could not be confirmed; however, it is possible that the guide wire break noted during return analysis was inadvertently reported as delaminated, but this could not be confirmed.The reported difficult to advance could not be tested due to the device condition.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/complaints from this lot.The investigation was unable to confirm the reported peeled/delaminated.The reported difficult to advance appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.H3, h10: the device was returned for analysis.H6: type of investigation code 4114 was removed.H6: investigation conclusions code 4315 was removed.

• 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 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 17191964
• Report Number: 2024168-2023-06672
• Device Sequence Number: 5642272
• Product Code: DQX
• UDI-Device Identifier: 08717648198496
• UDI-Public: 08717648198496
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 09/13/2023

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: 02/28/2025
• Device Catalogue Number: 1013319J
• Device Lot Number: 3031071
• 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: 05/30/2023
• Supplement Date Received by Manufacturer: 08/22/2023
• Initial Report FDA Received Date: 06/23/2023
• Supplement Report FDA Received Date: 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2023
• 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