MAUDE Adverse Event Report: AV-TEMECULA-CT ACS HI-TORQUE IRON MAN GUIDE WIRE

Catalog Number	1001311S
Medical Device Problem Codes	Entrapment of Device (1212); Failure to Advance (2524); Device Damaged by Another Device (2915)
Health Effect - Clinical Codes	Vessel Or Plaque, Device Embedded In (1204); Unspecified Infection (1930)
Date of Event	01/15/2019
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 incidents from this lot.The reported patient effect of infection is listed in the hi-torque guide wires instructions for use as a known patient effect of coronary stenting procedures.However, based on the reported information, the reported infection is not related to the device or the procedure.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.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 performed to treat a lesion in the right coronary artery with restenosis.The patient had a double layer of unspecified stents, and when the ironman guide wire (gw) was advancing, the gw became stuck in between the stents.The physician attempted to remove the gw; however, the stents became accordion-like; and therefore, the gw could not be removed.The patient was sent to bypass surgery.The gw was cut, and the distal portion was left to remain stuck in between the stents because it could not be retrieved in any way.The patient is currently in the intensive care unit (icu) and has two infections at unknown locations and delirium.It was noted that the patient developed a liver issue not related to use of the device.Per the physician, the device did not cause or contribute to the liver issue, delirium or infections.No additional treatment has been given to the patient.No additional information was provided.

• Brand Name: ACS HI-TORQUE IRON MAN 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: 8367414
• Report Number: 2024168-2019-01408
• Device Sequence Number: 16624538
• Product Code: DQX
• UDI-Device Identifier: 08717648013652
• UDI-Public: 08717648013652
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/25/2019

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: 06/30/2020
• Device Catalogue Number: 1001311S
• Device Lot Number: 8071161
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2019
• Initial Report FDA Received Date: 02/25/2019
• 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