MAUDE Adverse Event Report: PHILIPS VOLCANO REFINITY CATHETER, SHORT TIP, 89900; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	89900
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.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 during a coronary procedure, inside the body during the second pullback, the manufacturer's catheter got stuck on the non-manufacturer's's guidewire, thus the wire and catheter were removed together as a system.No patient injury reported.This product problem is being submitted because the manufacturer's catheter became stuck on the non-manufacturer's guidewire and were removed as a system.
Additional Manufacturer Narrative
Block d9: corrected from (b)(6) 2021 to (b)(6) 2021.Block h3: the refinity catheter was returned intact to a non-manufacturer's's guidewire and was visually and microscopically inspected.The distal tip was bent and there was a tear at the guide wire exit port.During functional testing, the guidewire movement test could not be conducted due to the stuck guidewire that could not be removed.Block h6: the probable cause of the reported "guidewire movement issue" could not be determined by the investigation since the guidewire test could not be performed.

• Brand Name: REFINITY CATHETER, SHORT TIP, 89900
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): PHILIPS VOLCANO; 3721 valley centre drive; #500; san diego CA 92130
• MDR Report Key: 12183819
• Report Number: 3008363989-2021-00001
• Device Sequence Number: 19237813
• Product Code: OBJ
• UDI-Device Identifier: 00845225002831
• UDI-Public: (01)00845225002831(11)210524(17)230524(10)0302280625
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K160583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2021

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: 05/24/2023
• Device Model Number: 89900
• Device Catalogue Number: 400-0200.273
• Device Lot Number: 0302280625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/22/2021
• Supplement Date Received by Manufacturer: 07/23/2021
• Initial Report FDA Received Date: 07/16/2021
• Supplement Report FDA Received Date: 07/30/2021
• 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: ABBOTT: BMW GUIDEWIRE, SIZE UNK; EBU GUIDE CATHETER MFG AND SIZE UNK; UNK MFG AND SIZE: INTRODUCER SHEATH