MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA TERUMO GLIDECATH CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number N/A

Device Problems Material Separation (1562); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/17/2022

Event Type  Injury  

Manufacturer Narrative

Implanted date: device was not implanted.Implanted date: device was not implanted.Occupation: interventional radiology (ir).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 manufacturing record and the product-release judgement record of the involved product/lot number combination confirmed there was no problem in them.A search of the complaint file found no similar report with the involved product code/lot number combination from other facilities.(b)(4).

Event Description

The user facility reported that the tip of the glidecath involved broke off during a case.The broken piece was able to be retrieved and removed.The patient was unharmed and was in stable condition.The outcome of the procedure was positive.The event occurred intra-operative.Additional information was received on 01 mar 2022: the procedure performed was a common iliac angioplasty.The event occurred after a very challenging crossing of bulky plaque.There was an abundance of force and friction involved, and the catheter was in a waltman loop (bent back on itself).The device broke about ten centimeters back from the tip.When the catheter was removed, the tip stayed in the aorta.A snare was used to remove the broken piece within one minute, and there was zero harm done.There was no blood loss.The broken tip was removed in its entirety as a single piece.

Manufacturer Narrative

H6: investigation findings - code 3211 is based upon the evaluation of user facility information and the investigation of the returned sample; code 213 is based upon outer diameter and inner diameter of the returned sample.The actual device has been returned for evaluation.Visual inspection of the actual sample obtained the following results: i) the shaft had been kinked at approximately 35 millimeters from the distal end.Ii) the shaft had been torn lengthwise from 75 millimeters to 10 millimeters from the distal end.Iii) the shaft had been fractured at approximately 155 millimeters from the distal end.The proximal end of the distal portion had been buckled.Magnifying inspection of the actual sample obtained the following results: i) the outer layer at the kinked section had not been torn.Ii) the inner layer at the tom area had been stretched.Iii) the inner wall at the proximal end of the torn area had been scratched.Iv) the fractured end of the distal portion had been deformed in trumpet-like shape.V) exposure of reinforcing mesh was observed at the fractured end of the proximal portion.X-ray fluoroscopic inspection of the fractured area revealed that the fracture had occurred at the end of reinforced section.Electron microscopic inspection of the actual sample obtained the following results: i) no scratches were observed at the kinked section.Ii) multiple scratches were observed near the torn area.Iii) multiple creases were observed at the distal end of the torn area.Iv) the fracture surface at the distal end of the torn area was smooth while the proximal end seemed to have been ripped off.V) the fracture end of the distal portion had been scratched.Vi) the fracture end of both portions seemed to have been ripped off.The outer diameter and inner diameter of the actual sample were measured and confirmed to meet the control standards.Based on the investigation results and the description of the complaint, it was presumed that the reported event occurred due to the following mechanism.I) when the actual sample was inserted to the target lesion, it came into contact with a calcified lesion and abraded.Ii) from the kink at approximately 35 millimeters from the distal end, it was inferred that the contrast media was flushed while the lumen was blocked due to the kink.As a result, the inner pressure increased causing the tear, which started from the abrasions, in the area from 75 millimeters to 100 millimeters from the distal end.Iii) some creases were observed at the distal end of the torn area while the proximal end seemed to have been ripped off; it was presumed that the tear might have developed from the proximal toward the distal side.Iv) since the stiffness of the shaft was deteriorated due to the tear, the actual sample became "bent back on itself".At this moment, the inner wall might have been exposed to the lesion, resulting in the abrasions on the inner wall.The actual sample might have been trapped because the actual sample was bent back on itself, and when the actual sample in that state was subjected to pushing and pulling manipulation, it might have buckled, and then fractured at the distal end of the reinforced section, which was the physical property transition point.Ashitaka factory is always continuing diligence in maintaining the product quality by performing extensive work and inspections, for example, as follows.I) in the catheter tube molding process, the core wire of which outside diameter is strictly controlled is covered with resin and then the core wire is removed from the resin.By this process, the inner diameter of the catheter shaft is assured.Ii) the product is free from any damage by conducting 100% visual inspection for any anomalies such as a kink or tear before the packing process.Iii) dedicated tools and containers are used to prevent generation of a kink or tear in the packing and cartoning processes.Please refer to the following instruction indicated in the ifu (instructions for use) of this product: "warning 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." "warning before starting infusion, verify that the catheter has not been kinked or blocked.Failure to abide by this warning may cause the catheter to break/rupture/separate, resulting in damage to the vessel.".

• Brand Name: TERUMO GLIDECATH CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: stephanie handy ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 9499890491
• MDR Report Key: 13825359
• MDR Text Key: 287897304
• Report Number: 9681834-2022-00038
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 04987350772213
• UDI-Public: 04987350772213
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K915414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/18/2022

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: 08/31/2023
• Device Model Number: N/A
• Device Catalogue Number: CG416
• Device Lot Number: 200902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2022
• Initial Date FDA Received: 03/19/2022
• Supplement Dates Manufacturer Received: 04/07/2022
• Supplement Dates FDA Received: 04/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention