MAUDE Adverse Event Report: PHILIPS VOLCANO VERRATA PLUS PRESSURE GUIDE WIRE, 185 CM STRAIGHT TIP; WIRE, GUIDE, CATHETER

Model Number	10185P
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal reference: (b)(4).Attempts to obtain the pt information has not been successful.Additional data: attempts to obtain the information has not been successful.Other tests: not applicable for this device.The implanted or explanted dates are not applicable to this device.Available for eval: not applicable for this device.Concomitant products: no information available.Country is (b)(6).(b)(4).Recall: do not apply to this submission.
Event or Problem Description
This case was reviewed and investigated according to the manufactures policy.It was reported during a coronary procedure, inside the body, before normalization, no signal was received and no physical damage was observed.Per additional information received, the device was intact upon removal.Visual and microscopic inspection were performed on the returned device.The sensor was broken and missing from the device.The probable cause for the separation may be due to the device being damaged during transit or initial unpacking.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.This product problem is being submitted since it could not be determined when the sensor separated from the manufactures device.There is a potential for harm if the malfunction were to recur.
Additional Manufacturer Narrative
Internal reference: (b)(4).Block b5: further review determined that this is not reportable for a product problem.Block h6: per the device evaluation, it concluded that the probable cause of the broken and missing sensor likely occurred during handling/return shipment.
Event or Problem Description
Mdr for product problem was inadvertently submitted.The probable cause for the broken and missing sensor likely occurred during handling/return shipment.Therefore, there is no potential for harm if the malfunction were to recur.
Additional Manufacturer Narrative
The health effect impact code 2199 and investigation conclusion code 4308 were inadvertently missed in supplemental mdr #1 submitted on (b)(6) 2021.There was no patient injury.Additionally, per the device evaluation, it concluded that the probable cause of the broken and missing sensor likely occurred during handling/return shipment.

• Brand Name: VERRATA PLUS PRESSURE GUIDE WIRE, 185 CM STRAIGHT TIP
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): PHILIPS VOLCANO; 2870 kilgore road; rancho cordova CA 95670
• Manufacturer (Section G): VOLCARICA S.R.L.; coyol free zone & business park; b37; alajuela ; CS
• Manufacturer Contact: 2870 kilgore road; rancho cordova, CA 95670 ; 7863902600
• MDR Report Key: 11639154
• Report Number: 2939520-2021-00014
• Device Sequence Number: 3052647
• Product Code: DQX
• UDI-Device Identifier: 00845225002879
• UDI-Public: (01)00845225002879(17)221130(10)0301794501(90)989609001231
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K161887
• Number of Events Summarized: 123
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/23/2021

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
• Device Expiration Date: 11/30/2022
• Device Model Number: 10185P
• Device Catalogue Number: 400-0300.38
• Device Lot Number: 0301794501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 03/12/2021
• Supplement Date Received by Manufacturer: 05/21/2021; 12/13/2021
• Initial Report FDA Received Date: 04/08/2021
• Supplement Report FDA Received Date: 05/24/2021; 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2019
• 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
• Patient Sex: Unknown