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	01/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal reference: (b)(4) this case was reviewed and investigated according to the manufacture¿s policy.Attempts to obtain the information has not been successful.Attempts to obtain the information has not been successful.Suspect products: not applicable for this device.Implant, explant, and device evaluation dates: not applicable for this device.Country is (b)(6).The record's reportability decision was incorrectly documented on the record following identification of the malfunction.Subsequently, this mdr is being submitted late.(b)(4).Remedial action/removal number: does not apply to this submission.
Event or Problem Description
It was reported that during a coronary procedure inside the body during measurement post normalization, the manufacturer's wire was advanced through the vessel when the physician noticed a loss of trackability and crossability with the guide wire.Upon removal, the tip was damaged and frayed, but remained in one piece.The procedure was successfully completed with a second manufacturer's wire.No patient injury reported.The returned device was visually and microscopically inspected.The distal coil was stretched, the core wire was broken in two parts, and sharp edges of the core wire was detected, but no missing parts were observed.This product problem is being submitted because a broken core wire with a sharp edges has a potential for harm if the malfunction were to recur.
Additional Manufacturer Narrative
Block h6: added codes 4721 (rod/shaft) and 2199 (no health consequences or impact).Corrected investigation findings code from the initial mdr from 3243 (stress problem identified) to 3252 (fracture problem).
Additional Manufacturer Narrative
Blocks a2-a5: patient information was provided.Blocks b6 & b7: patient information regarding relevant tests/laboratory data and medical history were provided.Block d10: concomitant devices were provided.

• 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: 11806044
• Report Number: 2939520-2021-00026
• Device Sequence Number: 17120947
• Product Code: DQX
• UDI-Device Identifier: 00845225002879
• UDI-Public: (01)00845225002879(11)201028(17)231028(10)0302067307
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• 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,Followup
• Report Date (Section B): 01/18/2021

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: 10/28/2023
• Device Model Number: 10185P
• Device Catalogue Number: 400-0300.38
• Device Lot Number: 0302067307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 06/06/2021; 05/12/2021
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 06/18/2021; 08/20/2021
• 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: MEDTRONIC: LAUNCHER GUIDE CATHETER SIZE UNK; TERUMO: RADIFOCUS INTRODUCER SHEATH, SIZE UNK; UNK MFG AND SIZE: GUIDE CATHETER; UNK MFG AND SIZE: INTRODUCER SHEATH
• Patient Age: 57 YR
• Patient Weight: 85