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	11/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer¿s policy.Not applicable for this device.Not applicable for this device.Country is (b)(6).The probable cause for the cracked and missing sensor could not be conclusively determined; however, manipulation and strain can damage the internal components.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 during a coronary procedure inside the body before normalization, the manufacturer's guide wire was used to take a few recordings and after the third recording, the pa pressure was unable to be detected.An attempt to reconnect the manufacturer's guide wire to the pim was not possible.The procedure was completed with the suspect manufacturer's wire.No patient injury reported.The returned device was visually and microscopically inspected.A portion (less than 0.02 mm) of the sensor was cracked and missing with rough edges 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 since it could not be determined when the sensor separated from the manufacture¿s device.There is a potential for harm if the malfunction were to recur.
Additional Manufacturer Narrative
Block h6: added codes sensor (510) and 2199 (no health consequences or impact).

• 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
• MDR Report Key: 11904779
• Report Number: 2939520-2021-00035
• Device Sequence Number: 4420454
• Product Code: DQX
• UDI-Device Identifier: 00845225002879
• UDI-Public: (01)00845225002879(17)230131(10)0301843885(90)989609001231
• Combination Product (Y/N): Y
• Initial Reporter Country: RP
• 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: 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: 01/31/2023
• Device Model Number: 10185P
• Device Catalogue Number: 400-0300.38
• Device Lot Number: 0301843885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/01/2021
• 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
• Patient Age: 76 YR
• Patient Weight: 87