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	06/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a coronary diagnostic procedure in a severely calcified mid rca, the refinity catheter was delivered over a non-manufacturer guide wire.During use, the physician struggled to maintain guide engagement throughout the procedure.Following the second successful ivus run pre-pci, the physician was unable to remove the catheter, thus was removed with the guide catheter and guide wire at the same time.Upon removal, it was noted that the guide wire was extensively bent and assumed the reason for the inability in trying to remove the catheter off the wire inside the vessel.The procedure was completed with a new refinity catheter.No patient injury reported.This product problem is being submitted due to the refinity catheter removed as a system and can result in a potential for harm.
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.Country is australia.The refinity catheter was not returned for evaluation, thus no returned product investigation was performed.Do not apply to this submission.
Additional Manufacturer Narrative
Blocks d9 & h3: refinity catheter was returned for evaluation.Block h3: visual inspection found damage from the distal tip to the rx port with rough edges of malleable material.During the guide wire movement test, a laboratory guide wire was inserted without difficulty or any resistance noted.Block h6: the reported complaint of the physician unable to remove the catheter from the guide wire could not be replicated with a laboratory guide wire.It is likely that the bent guide wire (not manufactured by philips) as stated in the initial mdr caused or contributed to the catheter getting stuck on the guide wire, resulting in removal as a system.Additionally, conclusion code #67 in the initial mdr remains appropriate since the reported complaint could not be replicated.

• 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
• Manufacturer (Section G): VOLCARICA S.R.L.; coyol free zone &business park; b37; alajuela ; CS
• Manufacturer Contact: danielle bullock ; 3721 valley centre drive #500; san diego, CA 92130
• MDR Report Key: 14880874
• Report Number: 3008363989-2022-00054
• Device Sequence Number: 12308848
• Product Code: OBJ
• UDI-Device Identifier: 00845225002831
• UDI-Public: (01)00845225002831(11)210624(17)230624(10)0302311094
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K160583
• 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): 08/12/2022

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: 06/24/2023
• Device Model Number: 89900
• Device Catalogue Number: 400-0200.273
• Device Lot Number: 0302311094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/09/2022
• Supplement Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 08/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2021
• 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: ASAHI: 0.014" SION BLUE GUIDEWIRE; MEDTRONIC: 6F LAUNCHER GUIDE CATHETER; TELEFLEX: 8F ARROW-FLEX INTRODUCER SHEATH
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian