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

Model Number	10185P
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.Block c: not applicable for this device.Blocks d6 & d7: not applicable for this device.Blocks e1 & g2: country is thailand.Blocks h3 & h6: the verrata 10185p was discarded at the facility, thus no returned product investigation was performed.Blocks h7 & h9: 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 a verrata 10185p wire was used in a diagnostic coronary procedure with a prior coronary stent.After completing the ifr measurement, the physician noticed small paint scraps of coating were on her surgical glove.No portion of the device separated inside the patient.The patient was fine with no injury reported.This product problem is being submitted because the verrata coating material peeled off.There is a potential for harm if the malfunction were to recur.

• Brand Name: VERRATA PLUS PRESSURE GUIDE WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): VOLCANO CORPORATION; 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 kharodawala ; 3721 valley centre drive #500; san diego, CA 92130 ; 858720-4063
• MDR Report Key: 18164020
• Report Number: 3008363989-2023-00054
• Device Sequence Number: 15257666
• Product Code: DQX
• UDI-Device Identifier: 00845225002879
• UDI-Public: (01)00845225002879(11)210714(17)240714(10)0302336063
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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): 11/17/2023

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: 07/14/2024
• Device Model Number: 10185P
• Device Catalogue Number: 10185P
• Device Lot Number: 0302336063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2021
• 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: 0.014, ASAHI SION BLUE GUIDE WIRE; 6F TERUMO GLIDESHEATH SLENDER INTRODUCER SHEATH; 6F TERUMO HEARTRAIL II BL 3.0 GUIDE CATHETER
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 63 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian