MAUDE Adverse Event Report: VERRATA 10185JP; WIRE, GUIDE, CATHETER

Model Number	10185JP
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reviewed and investigated according to the manufacturer¿s policy.No information available.Suspect products: not applicable for this device.Implant dates: not applicable for this device.Report city: country is (b)(6).The verrata 10185jp wire was discarded by the facility, thus no returned product investigation was performed.Manufacture : do not apply to this submission.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.
Event or Problem Description
It was reported that after a diagnostic coronary procedure, inside the body during pullback, the wire got stuck in the coronary vessel and broke, partly in the proximal lad and partly in the aorta.The operator removed half the wire from the patient and the patient required surgical intervention to remove the other half of the broken wire.No piece of the wire was retained in the patient.The ifr/ffr was successfully performed and stents were placed after the intervention.The patient is reportedly doing fine.No resistance noted during delivery.This adverse event and product problem is being submitted because the manufacturer's wire separated in the patient and required surgical intervention for removal.
Additional Manufacturer Narrative
Block d4: corrected catalog number from 400-0300.38 to 400-0300.39.

• Brand Name: VERRATA 10185JP
• Common Device Name: WIRE, GUIDE, CATHETER
• MDR Report Key: 12689832
• Report Number: 3008363989-2021-00020
• Device Sequence Number: 14484785
• Product Code: DQX
• UDI-Device Identifier: 00845225002886
• UDI-Public: (01)00845225002886(11)210708(17)240708(10)0302332622
• Combination Product (Y/N): Y
• Initial Reporter Country: PL
• PMA/510(K) Number: K161887
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2021

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: 07/08/2024
• Device Model Number: 10185JP
• Device Catalogue Number: 400-0300.39
• Device Lot Number: 0302332622
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/14/2021
• Supplement Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 10/25/2021
• Supplement Report FDA Received Date: 10/26/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MEDTRONIC: 6F LAUNCHER GUIDE CATHETER; UNK MFG AND SIZE: INTRODUCER SHEATH; MEDTRONIC: 6F LAUNCHER GUIDE CATHETER; UNK MFG AND SIZE: INTRODUCER SHEATH
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 75