MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA GLIDEWIRE ADVANTAGE; WIRE, GUIDE, CATHETER

Model Number	GA1430
Medical Device Problem Codes	Material Separation (1562); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that an.018 straight navicross catheter was advanced in the tp trunk over the.014 glidewire advantage.The physician then tried to pass the navicross through a tight lesion into the patient.The advantage wire was removed, a.018 platinum plus wire was inserted and removed.He had trouble pushing it over the wire.The physician then said it felt as if the catheter popped through.Once he retracted the navicross catheter back into the tp trunk, we saw remanence of what appeared to be the hydrophilic coating sluff off in the patient's vessel.It was possible that the advantage could have sluffed off inside the.018 navicross and then later exposed in the vessel once another wire was used, causing it to be pushed outside the catheter.The physician removed the navicross from the patient's vessel and there were two pieces of foreign body left behind.We had to snare the two pieces of black remanence out.The procedure performed was a peripheral angiogram.The blood loss was less than 250cc's.The reported event did not result in patient injury or surgical intervention.Additional information was received on 11oct2024: the sample was in the body and removed.The patient was stable.The procedure was completed after the removal of the foreign body.The additional devices used were a.014 glidewire advantage and snare to remove the foreign body.The patient was intubated and under a drape, making it hard to visualize.

• Brand Name: GLIDEWIRE ADVANTAGE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomya city, 418 ; JA 418
• MDR Report Key: 20559055
• Report Number: 2243441-2024-00034
• Device Sequence Number: 16944070
• Product Code: DQX
• UDI-Device Identifier: 04987350717924
• UDI-Public: (01)04987350717924(17)241130(10)221215
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/29/2024
• Report Date (Section F): 10/29/2024

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: 11/30/2024
• Device Model Number: GA1430
• Device Catalogue Number: RA*FA14301C
• Device Lot Number: 221215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/09/2024
• Device Age: 21 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/18/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2024
• 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: SNARE
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 88 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic
• Date Report Sent to FDA: 10/29/2024