MAUDE Adverse Event Report: PHILIPS VOLCANO 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	07/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.Relevant tests/laboratory data & other relevant history: no information available.Suspect product (s): not applicable for this device.Implant date/explant date & is this a single-use device that was reprocessed and reused on a patient? not applicable for this device.Initial reporter name and address & report source: country is poland.It is likely the cracked sensor occurred during the procedure; however, it could not be determined when the portion of the sensor was missing.The corrosion observed could have led to the sensor detaching due to the length of time from the date of event to evaluation (approximately 11 months).If remedial action initiated, check type & correction/removal reporting number: 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 during a diagnostic coronary procedure, the verrata 10185jp wire signal disappeared.A new verrata wire was used to complete the procedure.No patient injury reported.During the product return evaluation using a microscope, a portion of the sensor was cracked and missing with no sharp edges observed.Although it was confirmed that the device was intact during use, it cannot be determined at 100% because the missing sensor is not visible to the naked eye.This product problem is being submitted in abundance of caution due to a portion of the sensor missing.There is a potential for harm if the malfunction were to recur.

• Brand Name: VERRATA 10185JP
• 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: 14662192
• Report Number: 3008363989-2022-00053
• Device Sequence Number: 20365039
• Product Code: DQX
• UDI-Device Identifier: 00845225002886
• UDI-Public: (01)00845225002886(17)230331(10)0301900049(90)989609001241
• Combination Product (Y/N): N
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/10/2022

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: 03/31/2023
• Device Model Number: 10185JP
• Device Catalogue Number: 400-0300.39
• Device Lot Number: 0301900049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2022
• 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: 05/30/2022
• Initial Report FDA Received Date: 06/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2020
• 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: B. BRAUN: 6F INTRODUCER SHEATH; B. BRAUN: 6F JL 40 GUIDE CATHETER
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White