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

Model Number	N/A
Medical Device Problem Codes	Stretched (1601); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1: patient identifier: not available due to hospital policy.A2: age & date of birth: not available due to hospital policy.A3: patient sex: not available due to hospital policy.A4: weight: not available due to hospital policy.A5: ethnicity: not available due to hospital policy.A6: race: not available due to hospital policy.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E2: health professional: requested, not provided.E3: occupation: cvt.The actual device has been returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.Review of the manufacturing record and the shipping inspection record of the actual sample, no anomaly was found.Search of the past complaint file, no other similar report from other facilities was found.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.
Event or Problem Description
The user facility reported that the involved device wire was feeling strange during the procedure, therefore the wire was removed.The wire had a coating on the end portion of the wire.That portion of the wire had detached itself from the wire body.The procedure being performed was a leg intervention.Estimated blood loss was less than 250 cc.The event occurred intra-operative.The patient was not injured, medical or surgical intervention was not required.There is not a direct allegation that the reported device caused or contributed to patient injury and/or need for medical intervention.Additional information was received on 23 aug 2023: nothing was left in patient.Photo was provided of the item and package was provided with the ppr that has the lot# on it.No testing was performed to confirm the tip of the broken wire was removed from the patient because the wire was stretched out, not broken.Additional information was received on 24 aug 2023: the customer pulled the wire out of the patient in its entirety.All in one piece.Additional information was received on 25 aug 2023: product was a guidewire.Not infectious and no anti-cancer agents.The guidewire was placed with a like kind and the rest of the procedure was completed.Cannot recall if a stent or balloon had been inflated/deployed.The physician indicated that something didn't feel right, so he removed the guidewire.We were working on the patient's left with superficial femoral artery (sfa) right lesion to be stented.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to update section h3, and to provide the completed investigation results.The actual device has been returned for evaluation.Visual and magnifying inspections of the actual sample revealed: (i) that the urethane had been peeled off at the distal end; (ii) the exposed core wire was approximately 190 mm; (iii) the peeled urethane had been rolled up approximately 225 mm; (iv) the overlapping area was approximately 61 mm; (v) no scratch or other anomaly was found in the area where the urethane had been rolled up; (vi) no scratch or other anomaly was found in other sections.The outer diameter of ptfe coated part was confirmed to meet the factory's specifications.No anomaly was found.Past simulation test was conducted.An abrasion was made to the urethane layer of a test sample.The test sample was pulled in the withdrawal direction and drawn into the catheter.While the abrasion of the test sample was caught on the catheter, the pulling operation was continued.Test result, urethane was peeled toward the distal direction.From the results of the investigation, as one of the possibilities, it was thought that this event was caused by the following mechanism; however, since the details at the time of use were unknown, it was not possible to clarify the timing of occurrence.When the actual sample was used with a concurrently used device, the urethane layer of the actual sample was abraded by some hard object (e.G., stenotic lesion).When the actual sample in the state of (1) was pulled into the catheter (withdrawal operation), the abrasion area was caught in the catheter.As the withdrawal operation continued in the state of (2), the urethane was peeled toward the distal direction.Ashitaka factory is always making efforts to maintain the product quality by performing following controls.In the product assembling process, 100% visual inspection is performed to assure that there is no anomaly in the appearance.The instructions for use (ifu) of this product includes the following information: if any resistance is felt or if the tip's behavior and/or location seems improper, stop manipulating the glidewireadvantage and/or the catheter and determine the cause by fluoroscopy.Continuing to manipulate or rotate the glidewireadvantage 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: RADIFOCUS GLIDEWIRE ADVANTAGE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 17762181
• Report Number: 9681834-2023-00180
• Device Sequence Number: 15206400
• Product Code: DQX
• UDI-Device Identifier: 04987350703644
• UDI-Public: 04987350703644
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K063372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Model Number: N/A
• Device Catalogue Number: GA3502
• Device Lot Number: 230221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2023
• Supplement Date Received by Manufacturer: 09/12/2023
• Initial Report FDA Received Date: 09/16/2023
• Supplement Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2023
• 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
• Patient Sex: Unknown