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 Known Impact Or Consequence To Patient (2692)
Date of Event	02/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal reference: (b)(4).Facility declined to provide patient information; no information available.The implant or explant dates are not applicable to this device.Not applicable for this device.No information available.Do not apply to this submission.
Event or Problem Description
This case was reviewed and investigated according to the manufacture¿s policy.It was reported during a diagnostic coronary procedure, inside the body, after measurement, during pullback,the wire looked strange on the x-ray picture.When the physician removed the wire he recognized that the tip was unwound.Additional information provided, the physician kinked the wire by peeling over the introducing needle, no portion of the device became separated, or detached within the patient, and the device was intact/in one piece upon removal.Visual and microscopic inspection were performed on the returned device.The distal coil was stretched, the core wire was broken in two parts and exposed.All pieces of the core wire were accounted for.The damage to the distal coil and core wire likely occurred some time during preparation of the device for use.The manufacturing documentation for this device was reviewed, and the device met all quality and manufacturing release criteria.This product problem is being submitted because damage observed on the returned device of exposed and protruding components has a potential for harm if the malfunction were to recur.

• 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: 9861678
• Report Number: 2939520-2020-00010
• Device Sequence Number: 14310786
• Product Code: DQX
• UDI-Device Identifier: 00845225002879
• UDI-Public: (01)00845225002879(17)221231(10)0301805692(90)989609001231
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K161887
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/25/2020
• Report Date (Section F): 01/01/2005

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: 12/31/2022
• Device Model Number: 10185P
• Device Catalogue Number: 400-0300.38
• Device Lot Number: 0301805692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 03/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005