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

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem Calcium Deposits/Calcification (1758)

Event Date 03/03/2022

Event Type  Injury  

Event Description

The user facility reported that the glidecath device involved sheared off inside the patient due to severe calcium deposits.The piece was retrieved with a snare and the patient was unaffected.There patient condition was fine.The procedure outcome was fine.There was no patient injury/surgical intervention required.Additional information was received on 29 mar 2022: the procedure performed was a thromboendoarterectomy femoral artery and abd aortography.

Manufacturer Narrative

Lot number: requested, unknown.Expiration date: unknown due to unknown lot number.Implanted date: device was not implanted.Implanted date: device was not implanted.Occupation: sr.Project manager, clinical.Device manufacture date: unknown due to unknown lot number.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.Since the lot number was unknown, history inspections could not be performed.Since the lot number was unknown, only di number is listed.(b)(4).Please see mdr 2243441-2022-00009 for the importer report.

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.Visual inspection of the actual obtained the following results: i) the sample had been deformed at the distal end; ii) the sample had been fractured at approximately 155 millimeters from the distal end.Magnifying inspection obtained the following results: i) the deformed section of the sample had been dented over the entire circumference.Ii) the fractured section of the sample had been buckled and bent at the fractured section on the distal end; iii) the end positions of the inner layer and the outer layer were different at the fractured section on the rear end side.The inner layer and the reinforcement had been exposed; iv) the end of inner layer of the fractured section on the rear end side had an inclined shape; v) it had been flattened at the fractured surface on the distal end; vi) no flatness was found at the fractured surface on the rear end side, and the lumen was retained.X-ray fluoroscopic inspection of the lumen side of the fractured section found that there was no reinforcement at the fractured section on the distal end side and a part of the inner layer was missing.Electron microscopic inspection obtained following results:i) the deformed section of the sample seemed to be twined around the entire circumference was found.Ii) the fractured section of the sample had a tear shape was found at the fractured sections on both the distal end side and the rear end side; iii) abrasions and contact marks were found at the fractured section on the distal end side; iv) a dent was found at the end of outer layer on the rear end side; v) an abrasion and surface roughness were found in the vicinity of fractured section on the rear end side; vi) the outer and inner diameters were measured and confirmed to meet the specifications.The following mechanism of occurrence was presumed from the condition and the reported issue of actual sample.Arasions and contact marks were found at the fractured section, it was inferred that the surface of actual sample was in strong contact with the calcified lesion and was trapped.In addition, since the lumen of fractured surface on the rear end side was retained, inferred that it was combined with the involved guidewire at this time.Since the end positions of the inner layer and the outer layer were different, and a dent was found at the end of outer layer on the rear end side, as a result of operating the actual sample in the removal direction to release the trap, it was inferred that only the outer layer was fractured and it was buckled toward the distal end side.Pulling force was continuously applied, the inner layer of actual sample was torn and sheared off at the end of reinforcement, which is the transitional part of the physical properties.As a cause of deformation at the distal end, since it was dented over the entire circumference, and a shape that seems to be twined was found, it was inferred that the snare contacted during the retrieving of the fractured piece.Ifu (instructions for use) of this product includes the following warning."directions for use: 5.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.".

• 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: 13998719
• MDR Text Key: 289496351
• Report Number: 9681834-2022-00048
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 04987350772138
• UDI-Public: 04987350772138
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K915414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/04/2022

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 Model Number: N/A
• Device Catalogue Number: CG412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2022
• Initial Date FDA Received: 04/04/2022
• Supplement Dates Manufacturer Received: 04/19/2022
• Supplement Dates FDA Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: SNARE.
• Patient Outcome(s): Required Intervention