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

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Vascular Dissection (3160)

Event Date 05/09/2022

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing record and the shipping inspection record of the involved product code/lot number combination confirmed that there were not any indications of anomaly in them.A search of the complaint file found no other similar report for the involved product code/lot number combination from other facilities.Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).

Event Description

The user facility reported a middle third rupture in the microcatheter after attempted microcatheterization of a bronchial artery.The final patient impact was not harmed.Additional information was received on 07 jul 2022: there was no passage of hemostasis material such as coils or particles, only injections of contrast product were performed before it ruptured.The progreat 2.4 fr catheter was in a 5fr rdc catheter with a single-way stopcock at its end.The tip of the catheter broke off partially in the patient, a portion was still in the catheter.The microcatheter was removed by suctioning with a syringe.There were no difficulties/resistance felt before the rupture.Since the event occurred at the end of the procedure, no replacement catheter was needed.There was no real impact on the therapeutic management, however it precipitated the end of the procedure.Ending the procedure was due to the bronchial artery being dissected after several attempts at catheterization and therefore was more accessible for injecting an embolizing agent.

Manufacturer Narrative

The actual sample was returned for investigation.Visual inspection of the actual sample found that the catheter had been cut off in two places; therefore, it was inferred that the "rupture" described in the reported issue was this cutting section.The length of the cut piece was approximately 6mm.The length of each section of the actual sample was measured.The length of the distal side was approximately 744mm.The length of the cut piece was approximately 6mm.The length of the hand side was approximately 750mm.The total length was approximately 1500mm.Since the involved product was a 1500mm type, it was inferred that there was none missing.Magnifying inspection of the cutting section found that the stainless-steel reinforcement had been exposed and the cutting section had been crushed in an oval shape.The outer and inner diameters of the actual sample (normal section) were measured and confirmed to meet the specifications.During a simulation test a factory-retained progreat was inserted into a factory-retained angiographic catheter (glidecath, with a stopcock).In the state of "1", the operation of closing the stopcock by approximately 90 ° was performed.After operating the stopcock, progreat was removed from the angiographic catheter and visual inspection of it was performed.It was found that the stopcock operating section was cut off in two places.The length of the cut piece was approximately 6mm.Magnifying inspection of the cutting section found in "3" found that the stainless-steel reinforcement was exposed and the cutting section was crushed in an oval shape.It was very similar to the actual sample.Based on the investigation result, it was likely that since the stopcock was operated with the actual sample inserted in the device and used in combination, the actual sample was caught in the stopcock and cut off.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.".

• 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: 15025970
• MDR Text Key: 295955160
• Report Number: 9681834-2022-00134
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K033583
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/15/2022

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: MC-PP24151ZV
• Device Lot Number: 210914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/23/2022
• Initial Date FDA Received: 07/15/2022
• Supplement Dates Manufacturer Received: 07/15/2022
• Supplement Dates FDA Received: 08/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2021
• 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: 5FR RDC CATHETER
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Weight: 88 KG