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

Model Number RF*ZB5410GA

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 11/08/2019

Event Type  Injury  

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 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.

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 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.
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 9460819
• MDR Text Key: 185519654
• Report Number: 9681834-2019-00211
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 04987350772077
• UDI-Public: 04987350772077
• Combination Product (y/n): N
• PMA/PMN Number: K915414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 12/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: WIRE
• Patient Outcome(s): Other