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

Model Number N/A

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/19/2023

Event Type  Injury  

Manufacturer Narrative

A1: patient identifier: requested, not provided.A2: age & date of birth: requested, not provided.A3: patient sex: requested, not provided.A4: weight: requested, not provided.A5: ethnicity: requested, not provided.A6: race: requested, not provided.D4: udi: n/a as this product code is not exported to the us market.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.G4: pma/510(k): k033913.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.The manufacturing record and the shipping inspection record of the product with the involved product code/lot# no anomaly was found.The past complaint file of the product with the involved product code/lot#.No other similar report from other facilities was found.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

Event Description

The user facility reported that the interventional vascular radiologist was treated, a patient that suffers hcc.He used a 5f cobra glidecath of terumo, a mc-pb2413 progreat and a 0.014" gt guidewire of terumo with lipiodol.Everything was normal but when he removed the microcatheter as he ended the chemoembolization he noticed just a part of the microcatheter went out and an important part kept inside the glidecath.They are comun users of this microcatheter and it was a big surprise for them.They managed to recover the rest of the part of the microcatheter with a big syringue practicing negative aspiration until they recovered the rest of the microcatheter.They are sure they recovered all the microcatheter and inside the patient nothing remains.

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.Investigation of the actual sample: 1.1.Visual inspection of the actual sample · it had been cut at approximately 940mm from the distal end · the length of distal end side: approximately 940mm, the length of rear end side: approximately 354mm - since the total length of the product with the involved product code is 1300mm, it was presumed that there was a cut piece of approximately 6mm between the distal end side and the rear end side · the stainless steel reinforcement had been exposed from the cut sections (a) and (b).1.2.Magnifying inspection of the cut sections of actual sample: (a) side: the distal end had been crushed, and the stainless steel reinforcement had been exposed (a) top: the inner layer had been twisted (b) side: the distal end had been crushed, the stainless steel reinforcement had been exposed, and the inner layer had been cut (b) top: the inner layer had been crushed although red foreign substance was found in the part of lumen, no anomaly such as a scratch or kink was found.1.3 electron microscopic inspection of the cut sections of actual sample: (a): the inner layer had been torn and twisted, the outer layer had been torn, and the stainless steel reinforcement had been cut (b): the inner layer had been torn, the outer layer had been torn, and the stainless steel reinforcement had been cut 1.4.Confirmation of the dimension of actual sample: · the outer diameter (in the vicinity of cut section): it met the factory's specifications.No anomaly was found.Simulation test: i.In a state in which factory-retained progreat and the guidewire were combined, it was inserted into a factory-retained angiographic catheter (glidecath, with stopcock) and closed the stopcock of glidecath.Ii.After operating the stopcock, progreat was taken out from glidecath together with the guidewire, and visual inspection was performed.It was cut at two sections in the operation point.A cut piece between each cut section was approx.6mm.After the guidewire was removed, it was found at (c) that the distal end was crushed, the stainless steel reinforcement was exposed, and the inner layer was cut.It was found at the top of (c) that the inner layer was crushed.- this state was similar to that of the actual sample.Cause of occurrence/conclusion: based on the investigation result, it was likely that since the actual sample combined with the guidewire was inserted into the device used in combination, and the stopcock was operated, the actual sample was caught in the stopcock and was cut.Relevant ifu reference: "if the guiding catheter is fitted with a stopcock,do not close the stopcock with the micro catheter system inside the guiding catheter.The micro catheter system may be broken." 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).

• Brand Name: PROGREAT CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: gina digioia ; 950 elkton blvd; elkton, MD 21921 ; 6402040886
• MDR Report Key: 17168148
• MDR Text Key: 317532424
• Report Number: 9681834-2023-00118
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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,Followup
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• 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: MC-PB2413
• Device Lot Number: 220927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2022
• 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: TERUMO 0.014" GT GUIDEWIRE.; TERUMO 5F COBRA GLIDECATH.
• Patient Outcome(s): Required Intervention