MAUDE Adverse Event Report: AV-TEMECULA-CT ACS HI-TORQUE EXTRA SPORT GUIDE WIRE WITH MICROGLIDE COATING

Catalog Number	22225M
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562)
Health Effect - Clinical Codes	Vessel Or Plaque, Device Embedded In (1204); Bradycardia (1751); Occlusion (1984)
Date of Event	11/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 identified no other incidents from this lot.The reported patient effect of occlusion is listed in the hi-torque guide wires instructions for use (ifu) as a known patient effect of coronary stenting procedures.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.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that interaction with the heavily calcified anatomy and/or other devices resulted in the reported difficulty to remove.Manipulation of the device ultimately resulted in the reported detachment.The reported difficulties possibly caused/contributed to the reported patient effects however a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.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 heavily calcified lesions in the left main (lm) and obtuse marginal (om).A 3.5 guiding catheter was advanced and the sport extra guide wire advanced to the om.A 3.50x8 mm xience sierra stent was placed in the lm and a 2.25x18mm xience sierra was placed in the om.An attempt was made to remove the guide wire however it would not pull free from the distal portion of the vessel as it was hung up with the stent and the guide wire separated at the junction/distal end where the wire starts to turn silver.The om became occluded and the patient became bradycardic.A temporary pacemaker was placed and a surgical consult was called.The surgeon determined there was no need to remove the guide wire as it was stuck in the distal portion of the vessel and did not seem like it would embolize.The patient was in stable condition and will continue to be medically monitored.No force was applied during removal of the guide wire.The guide wire was not jailed beneath the stent.

• Brand Name: ACS HI-TORQUE EXTRA SPORT GUIDE WIRE WITH MICROGLIDE COATING
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8117925
• Report Number: 2024168-2018-09156
• Device Sequence Number: 13520043
• Product Code: DQX
• UDI-Device Identifier: 08717648079573
• UDI-Public: 08717648079573
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K060449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/29/2018

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: 08/31/2020
• Device Catalogue Number: 22225M
• Device Lot Number: 8091461
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2018
• Initial Report FDA Received Date: 11/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 62 YR