MAUDE Adverse Event Report: PHILIPS VOLCANO VERRATA 10185P; WIRE, GUIDE, CATHETER

Model Number	10185P
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a coronary procedure, the manufacturer's wire's tip appeared to be longer under angiography.A sharp edge was observed when removed from the patient.A second device was used to complete the procedure.No patient injury was reported.The returned device was visually and microscopically inspected.The distal coil was stretched and core wire was broken, but remained intact to the wire.The core wire was exposed and a sharp edge was confirmed.This product problem is being submitted for the sharp edge observed at the exposed core wire.There is a potential for harm if the malfunction were to reoccur.
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.(b)(6).The probable cause is damage in use.Manipulation and strain can damage the internal components.
Additional Manufacturer Narrative
Block a: updated to include patient information.Block e: updated physician name from dr.(b)(6) to dr.(b)(6).Block d10: updated to include brand name and size of a concomitant device.

• Brand Name: VERRATA 10185P
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): PHILIPS VOLCANO; 3721 valley centre drive; #500; san diego CA 92130
• Manufacturer (Section G): VOLCARICA S.R.L.; coyol free zone & business par; b37; alajuela ; CS
• Manufacturer Contact: in young rock ; 3721 valley centre drive; #500; san diego, CA 92130
• MDR Report Key: 12729701
• Report Number: 3008363989-2021-00022
• Device Sequence Number: 17296607
• Product Code: DQX
• UDI-Device Identifier: 00845225002879
• UDI-Public: (01)00845225002879(11)210514(17)240514(10)0302273328
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K161887
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2021

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: 05/14/2024
• Device Model Number: 10185P
• Device Catalogue Number: 400-0300.38
• Device Lot Number: 0302273328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2021
• Supplement Date Received by Manufacturer: 11/05/2021
• Initial Report FDA Received Date: 11/01/2021
• Supplement Report FDA Received Date: 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2021
• 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: MEDTRONIC: 6F GUIDE CATHETER.; UNK MFG AND SIZE: GUIDE CATHETER.; UNK MFG AND SIZE: INTRODUCER SHEATH.
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 67 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White