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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation- ir technologist.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.A review of the device history record and the shipping inspection record of the involved product code/lot# combination was conducted with no findings.Please see mdr (b)(4) for the importer report.(b)(4).
Event or Problem Description
The user facility reported that the involved glidecath was used intra-operative.They were doing a contra lateral retrograde access for a diagnostic angiogram of the lower extremity.They accessed the right and were going up the aortic bifurcation and to the other side.Advancing the wire first, then the catheter, and when the doctor was advancing over the bifurcation the front end detached from the second half.The catheter broke in two pieces and then the doctor had to snare the distal end to remove from the patient body.The patient was fine and was in stable condition.There was no blood loss.There is not a direct allegation.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date in section d9, update section h3, and to provide the completed investigation results.The actual sample was received for evaluation.The actual sample had been fractured into two portions of 155 mm and 510 mm in length, which were referred to as the fragment and the main body respectively in this report.Inspection of the fragment: magnifying inspection found that the edge of the fracture had been deformed in a trumpet shape.A torn off shape and elongation were observed.The same condition was observed from the reverse side.From this, it was inferred that the fracture was caused by a tensile load.The end of the fracture was observed from the top, and it was found to have been crushed from both sides.Two parts on the fragment (a and b) were checked for appearance under an electron microscope.The surface was rough, and abrasions were observed.The reverse side (a' and b') was found to be in the same condition.It was inferred that a hard object might have come into contact with the actual sample causing the rough surface, crushes and abrasions.Inspection of the main body: magnifying inspection found that the edge of the fracture had been deformed in a trumpet shape.Braided wire was exposed from the edge.The same condition was observed from the reverse side.The edge of the fracture was observed from the top, and it was found to have been opened outward.The inner layer had been elongated.From the investigation result 4 and 5, it was inferred that the fracture was caused by a tensile load.Electron microscopic inspection of two parts on the main body (c and d) found that the surface was rough.The part c was further magnified under an electron microscope, and an elongation was found.Electron microscopic inspection of the reverse side (c' and d') found that the surface was rough.The part c' was further magnified under an electron microscope, and a crushed mark was found.From the investigation result 6, it was inferred that the rough surface might have been caused by a hard object coming into contact with the actual sample, and the elongation might have been caused by a tensile load.Inspection of current product: the appearance of a current product was checked with a magnifier.There was no abnormality in the external condition.The appearance was checked with an electron microscope.There was no roughness or abrasion.Simulation test: a simulation test was performed by applying an excessive tensile load to a test sample trapped in a calcified lesion until it became fractured.Magnifying inspection of the test sample found that the fracture area was torn off and deformed into a trumpet shape.Exposure of the braided wire and elongation were observed.Surface roughness, elongation, and abrasions were observed upon electron microscopic inspection.The condition of the test sample was thought to be similar to that of the actual sample.The extent of roughness and elongation were thought to be dependent to the shape of the calcified lesion and the manipulation method, and they were formed larger in the simulation test sample.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 was likely that the actual sample might have come into contact with some hard object (e.G., calcified lesion) and trapped in it, and then fractured when exposed to an excessive tensile load while trapped.Based on the results of the simulation test, it was confirmed that the fracture may occur when glidecath ii is subjected to excessive tensile load while in contact with a calcified lesion.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
• MDR Report Key: 12041617
• Report Number: 9681834-2021-00113
• Device Sequence Number: 3877745
• Product Code: DQO
• UDI-Device Identifier: 04987350772190
• UDI-Public: 04987350772190
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K915414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2021

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: 05/31/2023
• Device Model Number: N/A
• Device Catalogue Number: RF*ZV9410GA
• Device Lot Number: 200609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2021
• Initial Date Received by Manufacturer: 06/04/2021
• Supplement Date Received by Manufacturer: 07/05/2021
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 08/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2020
• 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: AMPLATZ; AMPLATZ
• Outcome Attributed to Adverse Event: Required Intervention