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
Additional Manufacturer Narrative
A3b: gender: requested, not provided.A4: weight: requested, not provided.A6: race: requested, not provided.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: lead cardiovascular technologist.The actual sample was not available.However, since it is possible that some peeled pieces of the actual product remain in the concomitant device.No anomaly was found in the manufacturing record and the shipping inspection record.No other similar report was found in the past.Investigation will be performed once the concomitant device arrives at ashitaka factory, and it has been confirmed whether there are any peeled pieces.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
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.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide to provide the completed investigation results.The following additional investigations were performed: actual sample upon receipt: a navicross, no radifocus glidewire advantage was returned, and two pieces of retrieved foreign substances.Condition of actual navicross: no damage on the outer surface was found at the distal end or over the entire length.No anomaly such as a fracture or jumbling on the reinforcement or coil marker inside the actual sample was found at the distal end, the end at the hub side, or over the entire length.The inner diameter met the factory's specifications.No anomaly was found.Condition of foreign substances: each piece was black in color.Entire length of the foreign substance; foreign substance 1: approximately 6 mm, foreign substance 2: approximately 3 mm.Foreign substance 1 had been crushed, and the fractured section had been folded in an accordion shape.Foreign substance 1 had been abraded.Foreign substance 2 had been folded in an accordion shape over the entire length.The fractured section of foreign substance 2 had the torn shape.The spectrum of each piece measured by ft-ir (*) was similar to the mixed spectrum of protein and the outer layer of current product (radifocus glidewire advantage).It was possible that each foreign substance was the outer layer of radifocus glidewire advantage.Since the foreign substance had been removed from the patient's body, it was inferred that blood-derived proteins were being detected.Ft-ir (fourier transform infrared spectroscopy method): an analysis method to confirm the molecular structure of an object by analyzing the spectrum obtained by irradiating the measurement target with infrared rays.Based on the investigation result, no anomaly was found in the actual navicross.It was likely that each foreign substance that was retrieved was the outer layer of radifocus glidewire advantage.It was inferred that the surface of radifocus glidewire advantage came into contact with some hard object, causing the outer layer of involved section to be scraped off.However, since the actual sample was not returned, and details at the time of use it were unknown, it was not possible to clearly the cause of occurrence.Ashitaka factory has been making efforts in maintaining the quality of the product by performing following controls.Navicross: in the product assembling process, insert a core wire equivalent to the inner diameter, and 100% inspection is performed to confirm that it can be inserted.In the product assembling process, sliding resistance of the inner surface is confirmed on sampling basis that there is no anomaly in it.Before the packaging process, 100% visual inspection of the catheter is performed to confirm that there is no anomaly such as a kink or crush, then it is inserted into the holder tube.Radifocus glidewire advantage: the outer diameter of product is controlled to confirm that there is no anomaly in it.In the product assembling process, 100% visual inspection is performed to confirm that there is no anomaly such as exposure of the wire or deformation.In the shipping inspection, slidability test is performed on sampling basis for each lot.The ifu of this product includes the following warning: "if any resistance is felt or if the tip's behavior and/or location seems improper, stop manipulating the glidewire advantage and/or the catheter and determine the cause by fluoroscopy.Continuing to manipulate or rotate the glidewire advantage or failure to exercise proper caution may result in bending, kinking, separation of the guide wire's tip, damage to the catheter, or damage to the vessel.".

• Brand Name: GLIDEWIRE ADVANTAGE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomya 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 ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 9499890491
• MDR Report Key: 20559267
• Report Number: 9681834-2024-00201
• Device Sequence Number: 11538843
• 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
• PMA/510(K) Number: K122590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2024
• Supplement Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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