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	04/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer¿s policy.Country is (b)(6).The refinity catheter device has not been returned, thus no returned product investigation was performed.The health effect impact code (heic) field was intentionally left blank.A supplemental mdr to follow upon availability to enter code: 2199 (no health consequences or impact).Do not apply to this submission.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.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 the alleged death or deterioration in the state of the health of any person.
Event or Problem Description
It was reported that during a therapeutic coronary procedure inside the body post stenting, the manufacturer's catheter was used in the left main into the lad, cx, and intermediate branch.During removal, the manufacturer's catheter got stuck.It appeared the guidewire was tangled and twisted around the manufacturer's catheter.The physician was able to remove the guide wire and manufacturer's catheter as a unit.A new manufacturer's catheter was used to complete the procedure.No patient injury reported.This adverse event is being submitted because additional intervention was required to remove the manufacturer's device.
Additional Manufacturer Narrative
Internal reference: 9b)(4).This complaint was reviewed and investigated according to the manufacturer¿s policy.Blocks d10 & g4: the refinity catheter was returned for evaluation on 05/13/2021.Block h3: the returned device was visually and microscopically inspected.The manufacturer''s catheter was returned intact to a non-manufacturer''s wire, but was able to be removed from the manufacturer''s catheter.A zipper tear was observed from the guidewire exit port to the distal shaft of the manufacturer''s catheter.In addition, a portion of the distal shaft was stretched and twisted.During functional testing, guidewire test could not be performed due to the several damage observed on the device.Block h6: the probable cause of the reported guidewire movement issue could not be determined by the investigation due to the nature of the returned device.
Additional Manufacturer Narrative
Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer¿s policy.Block b1: corrected from adverse event to product problem.Block b2: does not apply, did not require intervention.Block b5: updated from adverse event to product problem.Block h1: corrected from serious injury to malfunction.Block g4: the initial report submitted 04-26-2021 had an inadvertent entry in block b1.Timeliness of submission is unaffected.Report is not late.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 the alleged death or deterioration in the state of the health of any person.
Event or Problem Description
This product problem is being submitted because the manufacturers device and another manufacturers device were removed together.
Additional Manufacturer Narrative
Internal reference: (b)(4).Block h6: added codes 4721 (rod/shaft), 2199 (no health consequences or impact), and 3243 (stress problem identified).

• 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: 11724058
• Report Number: 2939520-2021-00020
• Device Sequence Number: 3549955
• Product Code: OBJ
• UDI-Device Identifier: 00845225002831
• UDI-Public: (01)00845225002831(11)210217(17)230217(10)0302173147
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• 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,Followup,Followup
• Report Date (Section B): 04/14/2021

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: 02/17/2023
• Device Model Number: 89900
• Device Catalogue Number: 400-0200.273
• Device Lot Number: 0302173147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 04/26/2021; 05/13/2021; 06/06/2021
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 04/27/2021; 05/21/2021; 06/29/2021
• 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: 7.5F SHEATHLESS GUIDE CATHETER MFR AND SIZE UNK; ASAHI: SION BLUE GUIDE WIRE, SIZE UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Weight: 110