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

Model Number	89900
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint was reviewed and investigated according to the manufacturer¿s policy.Initial reporter & report source: country is (b)(6).The refinity catheter was received; however, device evaluation has not yet begun.A supplemental to follow upon completion of device evaluation.The user did not fully remove the air from the refinity catheter.The ifu warns that air entrapped in the catheter and flushing accessories can cause potential injury or death.Always verify that the catheter and flushing accessories have been properly cleared of air prior to inserting the catheter into the vasculature.
Event or Problem Description
It was reported during a therapeutic coronary procedure, that during preparation for use, the manufacturer's catheter was flushed multiple times with a lot of resistance encountered.However, the device was used in the patient, and during pullback, the images showed air entrapped in the catheter.A second manufacturer's catheter was used to complete the procedure.No patient injury reported.This product problem is being reported for the air entrapped in the catheter.There is a potential for harm if the malfunction were to recur.
Additional Manufacturer Narrative
Block h3/h6: the device was visually and microscopically inspected and found no damage observed.During functional testing, the flushing test and the resistance test both passed with no issues.Based on the device evaluation, the reported complaint could not replicated.Since no device malfunction was noted, it is likely the user did not fully remove the air from the catheter as documented in the initial mdr for investigation conclusion code 18: failure to follow instructions.
Additional Manufacturer Narrative
G: updated the city from costa rica to alajuela.Updated the country from united states (usa) to costa rica (cri).

• 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 pa; b37; alajuela ; CS
• Manufacturer Contact: danielle bullock ; 3721 valley centre drive; # 500; san diego, CA 92130
• MDR Report Key: 12969035
• Report Number: 3008363989-2021-00031
• Device Sequence Number: 4331835
• Product Code: OBJ
• UDI-Device Identifier: 00845225002831
• UDI-Public: (01)00845225002831(11)210727(17)230727(10)0302342370
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 11/11/2021

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: 07/27/2023
• Device Model Number: 89900
• Device Catalogue Number: 400-0200.273
• Device Lot Number: 0302342370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2021
• 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: 11/11/2021
• Supplement Date Received by Manufacturer: 12/09/2021; 04/07/2022
• Initial Report FDA Received Date: 12/09/2021
• Supplement Report FDA Received Date: 12/16/2021; 04/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2021
• 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: UNK MFG AND SIZE: GUIDE CATHETER; UNK MFG AND SIZE: GUIDE WIRE; UNK MFG AND SIZE: INTRODUCER SHEATH
• Patient Sex: Unknown