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

Model Number	10185
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal reference: (b)(4).This case was reviewed and investigated according to the manufacture¿s policy.No information available.Attempts to obtain the information has not been successful.No information available.Attempts to obtain the information has not been successful.Not applicable for this device.Not applicable for this device.Country is (b)(6).The probable cause for the sharp sensor housing could not be conclusively determined; however, manipulation and strain can damage the internal components.In addition, the health effect impact code (heic) field was intentionally left blank.A supplemental mdr to follow upon availability to enter code: 2199 (no health consequences or impact).Do not apply to this submission.
Event or Problem Description
It was reported that during a coronary procedure in the body post normalization and pre measurement, the manufacturer's guide wire displayed no pd pressure in the ivus image.Re-calibration was performed by unplugging the connector from the manufacturer's guide wire, but there was no connection between pa and pd.The returned device was visually and microscopically inspected.The sensor was raised above the sensor housing with a sharp edge observed.During functional testing, the manufacturer's guide wire failed the zero test, thus the drift test could not be performed.This product problem is being submitted because a sharp edge on the sensor housing has a potential for harm if the malfunction were to recur.
Additional Manufacturer Narrative
Internal reference: (b)(4).Block h6: added codes 510 (sensor) and 2199 (no health consequences or impact).

• Brand Name: VERRATA PRESSURE GUIDE WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): PHILIPS VOLCANO; 2870 kilgore road; rancho cordova CA 95670
• MDR Report Key: 11904776
• Report Number: 2939520-2021-00031
• Device Sequence Number: 19938475
• Product Code: DQX
• UDI-Device Identifier: 00845225002435
• UDI-Public: (01)00845225002435(17)220630(10)0301681319(90)989609001211
• Combination Product (Y/N): Y
• Initial Reporter Country: RP
• PMA/510(K) Number: K131288
• Number of Events Summarized: 123
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 10185
• Device Catalogue Number: 400-0300.16
• Device Lot Number: 0301681319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/05/2021
• Supplement Date Received by Manufacturer: 06/06/2021
• Initial Report FDA Received Date: 05/28/2021
• Supplement Report FDA Received Date: 07/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK MFG AND SIZE: GUIDE CATHETER.; UNK MFG AND SIZE: INTRODUCER SHEATH.