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	Perforation of Vessels (2135)
Date of Event	05/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer¿s policy.No information available.Attempts to obtain the information has not been successful.Not applicable for this device.Not applicable for this device.Device evaluation anticipated, but not yet begun.The health effect impact code (heic) field was intentionally left blank.A supplemental mdr to follow upon availability to enter code: (b)(4).(serious injury/ illness/ impairment).Do not apply to this submission.
Event or Problem Description
It was reported that during a coronary procedure inside the body while advancing to the mid rca, the manufacturer's catheter was loaded onto the non-manufacturer's's guide wire with no resistance noted.The catheter was turned on and at first displayed no image.On the angiogram, it did not appear that anything looked different.However, upon removal, the guide wire was wrapped/ entangled around the catheter.As a result, a small myocardial perforation was noted, but no stent was placed.The procedure was aborted and the patient was kept overnight for observation.The patient was ambulated and after a couple of hours of no chest pain, the patient was discharged home at the end of the day.This adverse event is being submitted because the patient experienced a perforation and required hospitalization.In addition, this product problem is being submitted because the manufacturer's catheter became entangled around the non-manufacturer's's guide wire and were removed as a unit.
Additional Manufacturer Narrative
Internal reference: (b)(4).Blocks d9 & g3: the refinity catheter was returned for evaluation.Block h3: the refinity catheter was returned with a non manufacturer's 0.014" guide wire, but not intact.The refinity catheter was visually and microscopically inspected and found a tear at the guide wire exit port; however, this does not affect the functionality of the device.During functional testing, a 0.015¿ mandrel was inserted through the distal end of the catheter and came out of the guide wire exit port without any resistance.The non-manufacturer's guide wire was able to be inserted into the refinity catheter freely, with no resistance noted.Block h6: the probable cause of the reported guidewire movement issue could not be determined since the catheter passed the guide wire test.

• Brand Name: REFINITY CATHETER, SHORT TIP, 89900
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): PHILIPS VOLCANO; 2870 kilgore road; rancho cordova CA 95670
• MDR Report Key: 11905480
• Report Number: 2939520-2021-00037
• Device Sequence Number: 17248370
• Product Code: OBJ
• UDI-Device Identifier: 00845225002831
• UDI-Public: (01)00845225002831(11)210324(17)230324(10)0302210628
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K160583
• 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
• Report Date (Section B): 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/24/2023
• Device Model Number: 89900
• Device Catalogue Number: 400-0200.273
• Device Lot Number: 0302210628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/05/2021
• Supplement Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 05/28/2021
• Supplement Report FDA Received Date: 06/23/2021
• 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: ASAHI: 0.014" PROWATER GUIDE WIRE; CORDIS: 8F BRITE TIP INTRODUCER SHEATH; MEDTRONIC: 8F LAUNCHER GUIDE CATHETER
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 68 YR
• Patient Weight: 64