MAUDE Adverse Event Report: ABBOTT VASCULAR DOC GUIDE WIRE EXTENSION

Model Number	22260
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device code (b)(4).The incident information was reviewed; however, 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 other similar incidents reported from this lot.It should be noted that the instructions for use for the doc guide wire extension, ce/fda states: carefully read all instructions prior to use.Failure to observe all warnings and precautions may result in complications.In this case, the physician is aware of that the device was used after the expiration date.The investigation determined the reported difficulties of device used after the expiration date appears to be related to user error.There were no specific reported device malfunctions or patient effects associated with the device.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.
Event or Problem Description
It was reported that this was a procedure to treat a lesion in the right coronary artery with heavy calcification and 90% occlusion.A doc guidewire (gw) extension was advanced with an unspecified device to the target lesion; however after insertion of the doc gw extension, it was observed that the gw extension had expired.The procedure continued with the doc gw extension, and the target lesion was successfully treated.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: DOC GUIDE WIRE EXTENSION
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11399946
• Report Number: 2024168-2021-01616
• Device Sequence Number: 3523808
• Product Code: DQX
• UDI-Device Identifier: 08717648013317
• UDI-Public: 08717648013317
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K931171
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/02/2021

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: 12/31/2020
• Device Model Number: 22260
• Device Catalogue Number: 22260
• Device Lot Number: 9010261
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 03/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 80