MAUDE Adverse Event Report: ABBOTT VASCULAR HT ALL STAR GUIDE WIRE

Model Number	1001741
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562)
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	11/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: estimated.G9: exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The customer reported the device was discarded.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 patient underwent a coronary stenting procedure.The stent delivery system was advanced over an allstar guide wire and the stent was implanted in the left anterior descending (lad) artery.During stent deployment, the stent jailed the diagonal artery.The allstar guide wire was removed from the lad and redirected into the diagonal artery.An attempt was made to advance an unspecified dilatation catheter over the guide wire; however, the dilatation catheter was unable to be advanced to the target site.An attempt was made to remove the guide wire; however, it was caught on the stent and separated in the patient anatomy.There was no attempt to remove the separated guide wire segment and balloon inflation was performed to adhere the guide wire to the vessel wall.No additional information was provided.
Additional Manufacturer Narrative
The product was not returned to abbott vascular for analysis.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 were 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 entrapment of the device and material separation appear to be related to operation circumstances of the procedure.Based on the reported information, the guide wire became trapped in the implanted stent during redirection into the diagonal artery.Manipulation against resistance resulted in the separation of the guide wire.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: HT ALL STAR GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9512880
• Report Number: 2024168-2019-14947
• Device Sequence Number: 16820038
• Product Code: DQX
• UDI-Device Identifier: 08717648013829
• UDI-Public: 08717648013829
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K972142
• 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): 02/10/2020

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: 1001741
• Device Catalogue Number: 1001741
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 02/10/2020
• 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: Required Intervention