MAUDE Adverse Event Report: PHILIPS VOLCANO VERRATA 10185P; WIRE, GUIDE, CATHETER

Model Number	10185P
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a diagnostic coronary procedure in a slightly tortuous vessel, the verrata plus guide wire was unable to advance due to resistance encountered; therefore, the wire and non-manufacturer's introducer sheath were removed as a unit.The procedure was completed with a new guide wire.No patient injury reported.This product problem is being submitted due to removal as a system.There is a potential for harm if the malfunction were to recur.
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.Report source: china.The verrata 10185p was not returned for evaluation, thus no returned product investigation was performed.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.
Additional Manufacturer Narrative
Block h3: the verrata wire was returned for evaluation.Visual inspection found no damage observed on the wire.During functional testing, the verrata was inserted into the guide wire bend text fixture, then tightened and rotated counterclockwise in quarter turn increments.Rotation was successfully propagated with distal tip movement noted.Block h6: based on the device evaluation, no failure was detected.The verrata wire functioned as intended.The complaint code listed in the initial mdr remain acceptable (67- investigation conclusion).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.

• Brand Name: VERRATA 10185P
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): PHILIPS VOLCANO; 3721 valley centre drive #500; san diego CA 92130
• Manufacturer (Section G): VOLCARICA S.R.L.; coyol free zone &business park; b37; alajuela ; CS
• Manufacturer Contact: ayse yarimoglu ; 3721 valley centre drive #500; san diego, CA 92130
• MDR Report Key: 15332504
• Report Number: 3008363989-2022-00066
• Device Sequence Number: 12478143
• Product Code: DQX
• UDI-Device Identifier: 00845225002879
• UDI-Public: (01)00845225002879(11)210127(17)240127(10)0302145364
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K161887
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2022

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: 01/27/2024
• Device Model Number: 10185P
• Device Catalogue Number: 400-0300.38
• Device Lot Number: 0302145364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2022
• Supplement Date Received by Manufacturer: 11/25/2022
• Initial Report FDA Received Date: 08/31/2022
• Supplement Report FDA Received Date: 12/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2021
• 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 EBU GUIDE CATHETER; UNK MFG AND SIZE: INTRODUCER SHEATH
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian