MAUDE Adverse Event Report: AV-TEMECULA-CT ACS HI-TORQUE FLOPPY II GUIDE WIRE

Model Number	22359M-901
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/07/2017
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.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 similar incidents reported from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.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 a lesion located in the second obtuse marginal branch.Resistance was felt during advancement of the ht floppy ii guide wire to the lesion.When the guide wire was retracted in a backward motion during the attempt to cross, resistance was felt and the guide wire tip separation occurred.The tip remained in the distal second obtuse marginal branch and was unable to be retrieved after multiple snaring attempts.The procedure was aborted due to the length of time that the patient remained on the operating table.Surgical removal of the tip was not performed.The patient was prescribed plavix and discharged from the hospital.It was stated that the guide wire crossed the lesion.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: ACS HI-TORQUE FLOPPY II 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: 6446868
• Report Number: 2024168-2017-02670
• Device Sequence Number: 588243
• Product Code: DQX
• UDI-Device Identifier: 08717648080326
• UDI-Public: (01)08717648080326(17)181231(10)7010561
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K060449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2018

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: 12/31/2018
• Device Model Number: 22359M-901
• Device Catalogue Number: 22359MS-901
• Device Lot Number: 7010561
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/09/2017
• Supplement Date Received by Manufacturer: 02/23/2018
• Initial Report FDA Received Date: 03/30/2017
• Supplement Report FDA Received Date: 02/26/2018
• 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: Required Intervention