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	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.The refinity catheter has not been returned for evaluation, thus no returned product investigation was performed.
Event or Problem Description
It was reported that during a therapeutic coronary procedure inside the body during pullback, the manufacturer's catheter got stuck to the non-manufacturer's stent in the severely tortuous and moderately calcified mid lcx and could not be retrieved.The shaft was cut for bail-out purpose, and after imaging core was removed, a 0.025 wire was introduced but was unsuccessful.The patient was transferred to another hospital for surgical intervention and reportedly recovering.The physician stated the adverse event was not caused by the manufacturer's catheter.This adverse event and product problem is being submitted because the patient required surgical intervention to retrieve the manufacturer's catheter that got stuck to the non-manufacturer''s stent.
Additional Manufacturer Narrative
Blocks d9 & h3: the refinity catheter was returned for evaluation.Block h3: the refinity catheter was visually and microscopically inspected.Only a portion of the catheter was received with a tear observed at the guide wire exit port.The remaining portion of the catheter were not returned: imaging core, telescope and connector.Block h6: the probable cause of the reported failure is damage during use as evidenced by the tear and the device purposely cut by the user to attempt removal from patient.Strain, impact, and forces associated with use can affect the integrity of the device.The ifu warns when the device has crossed a deployed stent, care should be taken when retracting the device to ensure that entanglement does not occur.

• 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: 12281275
• Report Number: 3008363989-2021-00002
• Device Sequence Number: 14445706
• Product Code: OBJ
• UDI-Device Identifier: 00845225002831
• UDI-Public: (01)00845225002831(11)210427(17)230427(10)0302236644
• Combination Product (Y/N): Y
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2021

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: 04/27/2023
• Device Model Number: 89900
• Device Catalogue Number: 400-0200.273
• Device Lot Number: 0302236644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/13/2021
• Supplement Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 08/05/2021
• Supplement Report FDA Received Date: 09/09/2021
• 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" SION BLUE GUIDEWIRE; MEDTRONIC: 7F LAUNCHER GUIDE CATHETER; TERUMO: 7F GLIDESHEATH INTRODUCER SHEATH; ASAHI: 0.014" SION BLUE GUIDEWIRE; MEDTRONIC: 7F LAUNCHER GUIDE CATHETER; TERUMO: 7F GLIDESHEATH INTRODUCER SHEATH
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention