MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RADIFOCUS INTRODUCER; INTRODUCER, CATHETER

Catalog Number RR-A50K10A

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/09/2022

Event Type  Injury  

Manufacturer Narrative

Lot number: requested, unknown.Expiration date: unknown due to unknown lot number.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)- k062858, k082644.Device manufacture date: unknown due to unknown lot number.The actual samples upon receipt were two plastic cannulas (sample 1 and 2).Visual inspection of sample 1 and 2 obtained following results: sample 1: the distal side was missing, and the total length was approx.60mm.Sample 2: no anomaly such as a missing part was found, and the total length was approx.82mm.The missing length of sample 1 was approx.22mm.In addition, the involved plastic cannula is manufactured by joining the tube and hub.The fractured section in this case was different from the joint section.Magnifying inspection of sample 1 found that it had been elongated.No anomaly such as a scratch was found in other sections.Therefore, it was inferred that it was fractured due to the application of pulling force.Electron microscopic inspection of sample 1 obtained following results: (i) a smooth shape was found on a part of fracture surface; (ii) a streak pattern was found on the fracture surface.Therefore, it was inferred that some sharp object came into contact with the plastic cannula.Magnifying inspection of sample 2 did not find any anomaly such as a scratch.Simulation testing was conducted from inspection of the actual sample, assuming that some sharp object may have come into contact with the plastic cannula, the following simulation test was performed using a plastic cannula and entry needle of the factory-retained product with the involved product code.After contacting the entry needle with the plastic cannula, electron microscopic inspection of the contact part was performed.As a result, a smooth shape and a streak pattern were found on a part of fracture surface.These conditions were likely to be similar to the condition of actual sample.Since the lot number was unknown, the manufacturing record and the shipping inspection record of the involved product code/lot# combination could not be reviewed.A search of the complaint file for past three years found two similar reports with the involved product code/lot# combination.In these cases, some sharp object came into contact with the plastic cannula, causing scratches, and when it was removed, pulling force was applied and it was fractured.Therefore, it was unlikely to be a product defect.Based on the investigation result and the simulation test result, it was likely that after some sharp object came into contact with sample 1 and a scratch was generated, pulling force was applied and the product was fractured starting from the scratch.In addition, the involved plastic cannula is manufactured by joining the tube and hub, and the joint is located at approx.61mm from the distal end.Therefore, if there is a manufacturing defect, the joint may fracture.However, since the fractured section in this case was different from the joint section, it was unlikely to be a product defect.Since the biological safety test of the involved plastic cannula is performed, its safety as a wetted material is assured.However, it is designed assuming contact in a short time, and there is no data on safety in case of contact over a long period of time or remaining it in the patient's body.Therefore, we are very sorry, but we could not clarify the complications caused by the fractured piece of plastic cannula remained in the patient's body.Relevant ifu reference: do not pinch the plastic cannula and/or the side tube with forceps.It may cause scratches on it.Attention should be paid not to damage the plastic cannula with forceps or sharp edged tools.(b)(4).

Event Description

The user facility reported that when the involved radifocus introducer product was used in the right jugular vein.After the plastic cannula was placed and the mini guidewire was inserted, the plastic cannula was removed.The plastic cannula was shortened and was found to have been fractured.Although it has not resulted in serious injury, the distal end of plastic cannula was missing, and the fractured piece has remained in the patient's body.The patient had minor harm but did not have serious injury.

• Brand Name: RADIFOCUS INTRODUCER
• Type of Device: INTRODUCER, CATHETER
• 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: 13980590
• MDR Text Key: 289495319
• Report Number: 9681834-2022-00045
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K033681
• 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
• Report Date: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RR-A50K10A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2022
• Date Manufacturer Received: 03/10/2022
• 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
• Patient Outcome(s): Other