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

Model Number RF*ZV9410GA

Device Problem Break (1069)

Patient Problems Blood Loss (2597); No Code Available (3191)

Event Date 02/13/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: month and year provided: (b)(6) 2020.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.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 (b)(4) for the importer report.(b)(4).

Event Description

Terumo medical received a user facility medwatch report # (b)(4).The event description states: "the procedure with this device was an attempt to revascularize the right external iliac artery stenosis.The attempt was thwarted because the intra-luminal catheter broke at the distal tip.It was retrieved from the patient's vasculature in its entirety by transfemoral wire and sheath access.A glidewire was advanced antegrade across the external iliac artery stenosis, across the common femoral and superficial femoral arteries.A 4 french angled glide cath was advanced over the wire and was used to exchange the stiff, angled glidewire for an amplatz wire.While withdrawing the angled glide catheter over the wire the distal end of it broke off, but remained on the amplatz wire." the original intended procedure: ultrasound guided percutaneous access of bilateral common femoral arteries; aortogram with right lower extremity with removal of fracture catheter.".

Event Description

Additional information was received on 19may2020.Blood loss was less than250cc.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide additional information in sections a2, a5, b3, and h6.Patient code.A correction is being provided in section d11.Concomitant medical products, the devices were inadvertently not listed in the initial report; therefore, they have been provided.It was initially reported in section h10.The a2.Date of birth was (b)(6) 2020; however, (b)(6) 1943 is the correct month and year.

Manufacturer Narrative

This report is being submitted as follow up no.2 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 fractured in two pieces.The main body was 485mm in length, and a fragment was 145mm in length.Each side of the fragment was called side-a or side-b.Approximately 50mm in length of both sides had been buckled.Evaluation of the fragment: magnifying inspection of side-a found some holes and lengthwise rips, the tip seemed to have been torn-off.Magnifying inspection of side-b found some holes and lengthwise rips.Electron microscopic inspection of side-a revealed that the edges of both the holes and lengthwise rips were smooth.From this, it was conceivable that a sharp-edged tool came into contact with them.Electron microscopic inspection of side-b revealed that the edges of both the holes and lengthwise rips were smooth.From this, it was conceivable that a sharp-edged tool came into contact with them.Evaluation of the main body: magnifying inspection of the main body seen from lateral side revealed that the reinforcing wire in the fractured area was exposed; fracture end had been deformed in a flare shape; no other anomaly was observed in the remainder part.Magnifying inspection of the fractured area from front side found that it had been flared and the inner layer had been elongated.Electron microscopic inspection of the reminder part did not find anomaly.Dimensional inspection: the outer and inner diameters were measured at the intact parts and confirmed to meet the manufacturer specifications.Reproductive testing was performed with a retention sample of the involved product code based on the assumption that the actual sample may have been subjected to excessive pulling force on the boundary between the reinforced and non-reinforced sections, where physical property of the shaft changes.The fracture end became deformed in a flare shape and the inner layer became 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 by some factors (e.G.Stenosed lesion), and then subjected to excessive pulling force while kept in that trapped state, resulting in the generation of the fracture.As for the holes and lengthwise rips, it was likely that the actual sample in the state of having been contacted with a sharp-edged tool was subjected to some force in the lengthwise direction.It was likely that the buckling of the actual catheter occurred when the concurrently used device, possibly in an insufficient primed state, may have become stuck in the actual sample, and then subjected 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: 10061749
• MDR Text Key: 198897335
• Report Number: 9681834-2020-00074
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 04987350772190
• UDI-Public: 04987350772190
• 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,Followup
• Report Date: 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: RF*ZV9410GA
• Device Catalogue Number: CG415
• Device Lot Number: 181228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2020
• Date Manufacturer Received: 06/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 4FR ANGLED GLIDE CATH; AMPLATZ
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 73