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

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/26/2022

Event Type  Injury  

Event Description

The user facility reported that after embolizing the collateral of the gastroduodenal artery (gda) with the azur cx device involved, in order to perform the gda angiography and to position the angiographic catheter, the micro catheter was removed.It was then found that a braiding wire was protruding from the tip and a part of the micro catheter remained in the patient.The vascular run was not steep, and no resistance was perceived at the proximal side during manipulation.As a possible cause, it was inferred that the micro catheter was fractured due accidental locking of the angiographic catheter's stopcock.The catheter remained in patient and was retrieved with a en snare.The procedure was completed successfully.The patient was not harmed.

Manufacturer Narrative

Udi: n/a as this product code is not exported to the us market.Implanted date: device was not implanted.Explanted date: device was not explanted.Pma/510(k): k033913, k170223.The samples returned for analysis were a progreat (the actual sample) and an angiographic catheter from another manufacturer (the angiographic catheter).Visual inspection of the actual sample was found to been fractured.The length of the distal portion and the proximal portion were approximately 350 millimeters and 953 millimeters respectively.Magnifying inspection of the actual sample found that the shaft had been stretched in the area approximately 50 mm - 125 mm from the distal end.In addition, a kink and a crush were observed at approximately 320 mm and at approximately 325 mm from the distal end, respectively.The distance between the two damages was approximately 5 mm.Magnifying inspection of the fractured sections of the actual sample found that the edge had been crushed and the reinforcing coil was exposed.The shape of the fractured surface was different between the distal portion and the proximal portion.Magnifying inspection of the angiographic catheter found no external anomalies such as a kink or crush in the shaft, or breakage in the stopcock.X-ray fluoroscopic inspection of the angiographic catheter found that the area from approximately 500 mm from the distal end to the vicinity of the stopcock had been clogged with contrast media.No other anomaly such as clogging, or breakage was observed in the remainder part.The outer and inner diameters of the actual sample was measured in the undamaged area and confirmed to meet the factory's control standards.No anomaly was observed.A review of the manufacturing record and the shipping inspection record of the involved product/lot number combination confirmed there was no problem in them.A search of the complaint file found no other similar reports with the involved product code/lot number combination from other facilities.Simulation test provided the following results: operation to close to the stopcock by approximately 90°: a factory-retained progreat sample was inserted in the angiographic catheter from another manufacturer, then the stopcock was turned by 90° to close.As a result, the progreat sample was cut with no resistance perceived at two points with a distance of approximately 5 mm.The edges of fracture were found crushed and the reinforcing coil was exposed, which was very similar to the fracture of the actual sample.Operation to close the stopcock by approximately 45°: a factory-retained progreat sample was inserted in the angiographic catheter from another manufacturer, and then the stopcock was turned by 45°to close.As a result, a kink and a crush were caused in the shaft and the distance between the two damages was approximately 5 mm.This state was very similar to the state of the actual sample observed in the area approximately 320 mm - 325 mm from the distal end.Based on the results of the investigation, one of the possibilities in this case, it was inferred that the stopcock of the angiographic catheter was manipulated while the actual sample was still inserted in it, which resulted in the kink, crush and fracture of the actual sample.When the fracture of the shaft occurs due to the manipulation of the stopcock of the concurrently used catheter, it occurs at two points with a distance of approximately 5 mm.As for the fractured piece of actual sample, the investigation of the fracture piece could not be performed since it was not returned for analysis.As for the stretched area of the shaft approximately 50 mm - 125 mm from the distal end, it was likely that a tensile load was applied to the involved area; however, the exact timing of occurrence could not be clarified.Relevant ifu reference: "if the guiding catheter is fitted with a stopcock, do not close the stopcock with the catheter inside the guiding catheter.The catheter may be broken." terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).

• Brand Name: TERUMO PROGREAT 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: 14495210
• MDR Text Key: 292582768
• Report Number: 9681834-2022-00091
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K033583
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/25/2022

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: 11/30/2022
• Device Model Number: N/A
• Device Catalogue Number: MW-CC23
• Device Lot Number: 201224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/26/2022
• Initial Date FDA Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/24/2020
• 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
• Treatment: MEDIKIT 5FR ANGIOGRAPHIC CATHETER TWIST
• Patient Outcome(s): Required Intervention