MAUDE Adverse Event Report: AV-TEMECULA-CT HT VERSATURN GUIDE WIRE

Catalog Number	1013319
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	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	04/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).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 similar incidents from this lot.It should be noted that per ifu, hi-torque guide wire, pta, ptca, stents, instructions for use states: 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: push, auger, withdraw, or torque a guide wire that meets resistance.Torque a guide wire if the tip becomes entrapped within the vasculature.In this case, the reported violation of the ifu does appear to have contributed to the reported tip separation as force and manipulation (pushing back and forth) was used to remove or retract the guide wire.The investigation determined the reported difficulties appear to be related to operational circumstances of the procedure.Based on the reported information, during advancement of the wire, the wire encountered resistance with the anatomy causing difficulty to position, and the wire to get stuck causing the difficulty to remove.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 the proximal left anterior descending artery (lad).A 190 cm versaturn guide wire was advanced.After the delivery of an intravascular ultrasound (ivus) catheter, an unspecified balloon catheter was used and an unspecified stent was deployed.However, attempts to remove the versaturn guide wire were unsuccessful as it was stuck in the distal lad.The device was finally removed after several attempts to push and pull it (force was applied); however, the tip became separated.The angiogram showed the tip remained in the distal lad.Medical intervention was not performed as the tip was stuck in the distal part of the lad.The patient is stable and does not show any symptoms; the electrocardiogram (ecg), blood test and troponin i test were normal.No additional information was provided.
Additional Manufacturer Narrative
Internal file number - (b)(4).Conclusion code 18 removed.Correction - device code 2017 removed.The following was removed from the qe analysis: it should be noted that per ifu, hi-torque guide wire, pta, ptca, stents, instructions for use states: if resistance is observed at any time, determine the cause under flouoroscopy and take remedial action as needed.Use the most suitable guide wire for the lesion being treated.Do not: push, auger, withdraw, or torque a guide wire that meets resistance.Torque a guide wire if the tip becomes entrapped within the vasculature.In this case, the reported violation of the ifu does appear to have contributed to the reported tip separation as force and manipulation (pushing back and forth) was used to remove or retract the guide wire.
Event or Problem Description
Subsequent to filing the initial/final mdr, additional information was received.Excessive force was not applied on the device during pushing and pulling.No additional information was provided.

• Brand Name: HT VERSATURN GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8588211
• Report Number: 2024168-2019-03619
• Device Sequence Number: 19242242
• Product Code: DQX
• UDI-Device Identifier: 08717648198458
• UDI-Public: 08717648198458
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K103101
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2019

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: 10/31/2020
• Device Catalogue Number: 1013319
• Device Lot Number: 8112661
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/16/2019
• Supplement Date Received by Manufacturer: 07/03/2019
• Initial Report FDA Received Date: 05/07/2019
• Supplement Report FDA Received Date: 07/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INTRAVASCULAR ULTRASOUND (IVUS) CATHETER; INTRAVASCULAR ULTRASOUND (IVUS) CATHETER
• Outcome Attributed to Adverse Event: Other