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

Model Number RF*ZV94110A

Device Problem Break (1069)

Patient Problem Blood Loss (2597)

Event Date 10/14/2019

Event Type  Injury  

Manufacturer Narrative

Patient weight: (b)(6) kgs, implanted date: device was not implanted, explanted date: device was not explanted.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 product release decision control sheet of the product code/lot# combination was conducted with no findings.(b)(4).Please see mdr 2243441-2019-00106 for the importer report.

Event Description

The user facility reported that the involved glidecath broke off in the patient.Additional information was received on (b)(6) 2019.While performing a peripheral angio of the right groin, going up and over in the left leg the glidecath broke off.The catheter was removed from the patient using a snare.The patient was reported to be stable.The procedure was completed successfully once removing the catheter.The blood loss was less than 250cc's.

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 shaft had been fractured at two points and separated into three pieces.The total length was confirmed to be 1036mm.Compared to the total length of a factory-retained sample of the same product code, which was 1010mm, the actual sample was found to have been elongated by 26mm.Fractured piece 1: 112mm; fractured piece 2: 214mm; main body: 710mm.Magnifying inspection of fracture point a (the proximal end of the fractured piece 1 and the distal end of the fractured piece 2): the shape of both fracture ends was fit with each other.This infers that the actual sample had no deficient section.The catheter tubes of both pieces had been compressed near the fracture end with two vertices generated on the diagonal position.The inner layer had been partially elongated.Magnifying inspection of fracture point b (the proximal end of fractured piece 2 and the distal end of the main body): abrasions and exposure of the reinforcement had occurred near the fractured distal end of main body.From this, it is inferred that a hard object was exposed to this point.Buckled outer layer had been found on the proximal end of fracture piece 2.It is presumed that the outer layer had been separated from the fractured end of main body.Elongation of the inner layer was observed on the fractured cross section of both pieces.The inner and outer diameters of the actual sample was measured on the intact section and confirmed to meet manufacturer specifications.Reproductive testing was performed and the non-reinforced section of a retention sample from the involved product code was pinched with a hard object (e.G.Scissor blades), and then exposed to pulling force until being fractured.The result showed that the fracture ends were deformed in a compressed shape with two vertices generated in the diagonal position.The reinforced section of a retention sample from the involved product code was exposed to pulling force until being fractured.The result showed that the fractured ends were deformed in a flare shape and the inner layer was elongated.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 fracture point a was caused by being pinched with a hard object (e.G., scissor blades).Fracture point b was likely to have been caused when the actual sample, after having been exposed to a hard object, was exposed to pulling force.However, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: RADIFOCUS GLIDECATH HYDROPHILIC COATED CATH.
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 9245242
• MDR Text Key: 179257820
• Report Number: 9681834-2019-00190
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 04987350772213
• UDI-Public: 04987350772213
• Combination Product (y/n): N
• PMA/PMN Number: K915414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/28/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: RF*ZV94110A
• Device Catalogue Number: CG416
• Device Lot Number: 180308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Initial Date Manufacturer Received: 10/15/2019
• Initial Date FDA Received: 10/28/2019
• Supplement Dates Manufacturer Received: 11/05/2019
• Supplement Dates FDA Received: 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 62