MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE EXTRA S'PORT GUIDEWIRE; GUIDE WIRE

Model Number	22225M
Medical Device Problem Codes	Entrapment of Device (1212); Stretched (1601); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number e2019001.The customer reported the device will not be returning.Investigation is not yet complete.A follow-up will be submitted with all relevant information.The other extra s'port guide wire and the xience sierra stent are filed under separate medwatch report numbers.
Event or Problem Description
It was reported that the patient underwent a coronary stenting procedure, treating a target lesion in the diagonal artery.The 2.25 x 12 mm xience sierra stent was implanted without issue.There was no difficulty noted during advancement or withdrawal of the stent delivery system.However, resistance was noted during removal of the extra s'port guide wire, as the guide wire was caught on the distal end of the stent.The guide wire coils stretched into the aorta.A guide liner was advanced into the guide catheter, in an attempt to push the coils back into the vessel.A second extra s'port guide wire was advanced to assist removal of the first guide wire.The second guide wire also got stuck on the stent.In the attempt to remove both guide wires, the stent was explanted with the guide wires.The left anterior descending (lad) artery was damaged during the removal attempts and an additional stent was implanted.The diagonal artery was not treated with additional stenting and no vessel damage was noted from the stent explantation.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned.A review of the electronic lot history record (elhr), corrective action tracking system for the web (catsweb) database review and similar incident query for this product was not performed since the lot number was not reported.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 and treatment appear to be related to operational circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: HI-TORQUE EXTRA S'PORT GUIDEWIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9508068
• Report Number: 2024168-2019-14919
• Device Sequence Number: 1542636
• 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: K950156
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2020

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 Model Number: 22225M
• Device Catalogue Number: 22225M
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 02/10/2020
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 03/02/2020
• 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: XIENCE SIERRA STENT, EXTRA S'PORT GUIDE WIRE
• Outcome Attributed to Adverse Event: Required Intervention