MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RADIFOCUS GLIDECATH HYDROPHILIC COATED CATH.; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	RF*ZB5410GA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device was not returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.A review of the device history record and product release decision control sheet of the product code/lot# combination was conducted with no findings.(b)(4).Please see mdr 2243441-2019-00121 for the importer report.
Event or Problem Description
The user facility reported that the doctor was trying to pull the catheter over a wire and the catheter snapped in to multiple pieces.The patient was reported to be in stable condition.The procedure outcome was successful.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide additional information in section b5, and to provide the completed investigation results.A factory-retained sample of the involved product code/lot# was inspected.Visual inspection did not find a flaw, break, or any other visible anomaly in it.Magnifying inspection of the catheter tube lumen at both distal and proximal ends did not find an obstruction, deformity, or any other visible anomaly.Dimensional testing was performed.The outer and inner diameters of the shaft were measured and confirmed to meet the factory's specifications.Functional testing was performed.The strength of the shaft against bending force was evaluated and confirmed to meet the factory's specifications.With no return of the actual device, the exact cause of the reported event cannot be definitively determined based on the available information.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 or Problem Description
Additional information was received on (b)(6) 2019.There was no catheter left in the patient and no further intervention was required.

• Brand Name: RADIFOCUS GLIDECATH HYDROPHILIC COATED CATH.
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 9460819
• Report Number: 9681834-2019-00211
• Device Sequence Number: 19602447
• Product Code: DQO
• UDI-Device Identifier: 04987350772077
• UDI-Public: 04987350772077
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K915414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: RF*ZB5410GA
• Device Catalogue Number: CG409
• Device Lot Number: 190422
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/14/2019
• Supplement Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 12/12/2019
• Supplement Report FDA Received Date: 01/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: WIRE
• Outcome Attributed to Adverse Event: Other