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

Model Number	N/A
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	10/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation: study coordinator.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.Regarding the product codes gr3525 and gr3526, which were reported to be potentially involved in this case, the manufacturing record was checked to see if a combination with lot 200629 existed.As the combination of gr3525 and lot 200629 only was confirmed, it was conceivable that the involved product code was gr3525.Review of the manufacturing record and the product-release judgement record of gr3525/lot 200629 combination confirmed that there were not any anomalies in them.Regarding gr3525/lot 200629 combination, a search of the complaint file found no other similar from other facilities.According to the investigation results, no anomaly was found in the records regarding gr3525/lot 200629 combination.The actual sample was not available for analysis, in addition, the details of occurrence were unknown, therefore, it could not be clarified the causal link between the actual sample and the reported mild spasm.Ashitaka factory is always continuing diligence in maintaining the product quality by performing thorough work and inspections, for example, as follows.The outer diameter of the product is controlled.The homogeneity of the hydrophilic coating solution is guaranteed by controlling the balance of materials and the stirring time.The uniformity of the hydrophilic coating layer is guaranteed by controlling the application conditions (coating speed and immersion time).After the application of hydrophilic coating, sliding performance is checked to ensure that the hydrophilic coating has been applied properly.(b)(4).
Event or Problem Description
The source of this report came from a registry and the following adverse event was found on review: the user facility reported that the patient had a mild spasm in the radial artery upon advancement of the 1.5 mm j wire.The patient was in stable condition.The procedure outcome was successful.There was no patient injury/medical or surgical intervention required.Additional information was received on 18 feb 2022: the procedure performed was a prostatic artery embolization (pae).There was no medication given to the patient.There were no other procedures performed to mitigate the issue.A large tr band was used after the procedure.

• 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: stephanie handy ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 9499890491
• MDR Report Key: 13693131
• Report Number: 9681834-2022-00032
• Device Sequence Number: 1906070
• Product Code: DQX
• UDI-Device Identifier: 04987350707284
• UDI-Public: 04987350707284
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K863138
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/08/2022

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: 05/31/2022
• Device Model Number: N/A
• Device Catalogue Number: GR3525
• Device Lot Number: 200629
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2020
• 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: 75 & 200 MICROSPHERES; FATHOM 14; GLIDESHEATH SLENDER; SYNCHRO-2; TR BAND - LARGE
• Outcome Attributed to Adverse Event: Other
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White