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

Model Number	RF*ZM7410GA
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D6: implanted date: device was not implanted d7: explanted date: device was not explanted 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.For this reason, evaluation code 11 has been referenced in the conclusions section of h6.The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.Exemption number e2015022.
Event or Problem Description
The user facility reported the glidecath was inserted through 6 fr pinnacle r/o over amplatz wire.When it was removed, the tech noticed that the end of the catheter looked different than normal.It was quickly realized that a distal part of the catheter had broken off.The end of the catheter was easily retrieved with an ensnare device.The patient did fine and the rest of the procedure continued as normal.The patient was unaffected and did fine.The procedure outcome was reported to be a success.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date in section and the completed investigation.The actual device was returned for evaluation.Visual inspection upon receipt revealed that the shaft had been fractured at approximately 150mm from the distal end of the device.On approximately 97 -150mm from the distal end, the shaft had been deformed into an accordion-like shape.Magnifying inspection of the distal fracture revealed that the fracture end had been stretched and flared with the segment adjacent to the fracture end having been deformed into a wavy shape.These findings imply that the actual sample was subjected to torque force and pulling force.On the segment adjacent to the fracture end, some abrasions were found.Magnifying inspection of the proximal fracture found the exposure of the braided wires (stainless steel reinforcement) at the fracture end.There was no abrasion around the fracture end.Magnifying inspection of the remainders of the device obtained the findings below.The distal extremity had been slightly deformed.On the segment approximately 93 - 96mm from the distal end of the device, a tear had been generated.On the tear cross-section, resin had been roughed.On approximately 81 - 104mm from the distal end of the device, there were some intermittent abrasions.There was no other anomaly than above mentioned damage.The outside and inside diameters were determined on the undamaged segment and confirmed to meet the specifications.The bending strength was determined on the undamaged segment and confirmed to be normal with no generation of a crack.Ifu states: manipulate the catheter slowly and carefully in the artery.Never advance or withdraw an intraluminal device against resistance until the cause of resistance is determined by fluoroscopy.Failure to exercise proper caution may result in damage to the vessel or catheter.Separation of the catheter may occur requiring retrieval in some cases.The radifocus glidecath should be used by a physician who is well trained in manipulation and observation under fluoroscopy.There is no evidence that this event was related to a device defect or malfunction.It is likely that the actual sample, in the state of being trapped by some factor(s), was exposed to torque force, when the torque force was concentrated to the transit point of the braided portion and non-braided portion of the shaft where the physical property changes and the shaft got distorted.By this distortion, the actual sample and the guide wire used in combination with the actual sample got trapped with each other.Subsequently, when an attempt to withdraw the actual sample was made, the actual sample got fractured at the trapped segment.The causes of the generation of the tear and abrasions on the actual sample cannot be determined as it is not known if they were generated when the actual sample was retrieved with the snare the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: RADIFOCUS GLIDECATH HYDROPHILIC COATED CATH
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• MDR Report Key: 7698183
• Report Number: 9681834-2018-00132
• Device Sequence Number: 13730028
• Product Code: DQO
• UDI-Device Identifier: 04987350772138
• UDI-Public: 04987350772138
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K915414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2018

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 Model Number: RF*ZM7410GA
• Device Catalogue Number: CG412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2018
• Initial Date Received by Manufacturer: 06/25/2018
• Supplement Date Received by Manufacturer: 07/20/2018
• Initial Report FDA Received Date: 07/18/2018
• Supplement Report FDA Received Date: 08/06/2018
• 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: AMPLATZ WIRE; PINNACLE 6 FR R/O SHEATH; AMPLATZ WIRE; PINNACLE 6 FR R/O SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 89 YR
• Patient Weight: 51