MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RADIFOCUS GLIDECATH HYDROPHILIC COATED CATH.; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	RF*ZV9410GA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	11/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.(b)(4).The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.For this reason, (b)(4).A review of the device history record and product release decision control sheet of the product code/lot# combination was conducted with no findings.(b)(4).Please see mdr 2243441-2019-00126 for the importer report.
Event or Problem Description
The user facility reported that the involved non-taper angled glidecath broke off during the procedure.The patient was in stable condition.Additional information was received on 20nov2019.The doctor had to snare the broken cath.Additional information was received on 18dec2019.During the procedure, the distal end of catheter broke off inside patient's aorta.The physician was able to snare piece that broke off and removed it from body; the complete catheter tip was removed.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date in section d10, update section h3, and to provide the completed investigation results.The actual sample was received for evaluation.Visual inspection revealed that the actual sample had been broken in two pieces.The aggregated length of both pieces was confirmed to be 700mm.Compared to the length of a factory-retained sample of the involved product code, which is 680mm, the actual sample was confirmed to have been elongated by 20mm.Length of the distal piece: approximately 160mm; length of the main body: approximately 540mm.Magnifying inspection of the distal piece from lateral side revealed that the area near the fracture end had been stretched; the fracture end had been deformed in a flare shape; scratches were observed on approximately 55mm from the distal end.From this, it was presumed that a hard object came into contact with that area.Magnifying inspection of the main body from lateral side revealed that the area near the fracture end had been stretched; reinforcing wire in the fractured area was exposed; the fracture end had been deformed in a flare shape.Magnifying inspection of both fracture ends from front revealed that the fracture ends had been deformed in a flare shape and the inner layer had been stretched; the fracture occurred on the end of the reinforced section; the outside and inside diameters were measured on the undamaged segment and confirmed to meet the manufacturer specifications.Reproductive testing was performed with a retention sample of the involved product code and revealed that the fracture end became deformed in a flare shape and the inner layer got elongated.Reinforcing wire was exposed on the fracture end.Ifu states: never advance or withdraw an intraluminal device against resistance until the cause of resistance is determined by fluoroscopy.Failure to exercise proper caution may result in damage to the vessel or catheter.Separation of the catheter may occur requiring retrieval in some cases.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.It is likely that the actual sample may have been trapped due some factors and then subjected to excessive pulling force, resulting in the generation of the fracture.However, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: RADIFOCUS GLIDECATH HYDROPHILIC COATED CATH.
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 9615878
• Report Number: 9681834-2019-00244
• Device Sequence Number: 19437129
• Product Code: DQO
• UDI-Device Identifier: 04987350772190
• UDI-Public: 04987350772190
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K915414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2020

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: 01/31/2022
• Device Model Number: RF*ZV9410GA
• Device Catalogue Number: CG415
• Device Lot Number: 190225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Initial Date Received by Manufacturer: 11/20/2019
• Supplement Date Received by Manufacturer: 03/02/2020
• Initial Report FDA Received Date: 01/22/2020
• Supplement Report FDA Received Date: 03/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention