MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION RADIFOCUS INTRODUCER II KIT; INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	10/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.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.A review of the device history record of the product code/lot# combination was conducted with no findings.This report is for the second device reported, for the firts device reported that was used on the same patient see mdr 1118880-2019-00316.
Event or Problem Description
The user facility reported that two ik sheaths were pulled after the act came down and it was discovered that both sheaths had been cut longitudinally along the length of the sheath cannula.The procedure was a bilateral common iliac revascularization.Bilateral 7 fr common femoral arterial access was gained.The physician ballooned the right then the left common iliac using one single boston scientific 7mmx2cm peripheral cutting balloon.7mmx60mm and 7mmx80mm in pact admiral drug elating balloons were then used to treat the left and right lesions, respectively.Arteriography at the end of case demonstrated that there was no trauma dissection/perforation to the patient's vasculature.The patient was reported to be in stable condition.The procedure outcome was successful.Blood loss was less than 250cc.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to update sections and to provide the completed investigation results.Initally it was reported that the device was available, however has been confirmed to be not available.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.With no return of the actual device, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: RADIFOCUS INTRODUCER II KIT
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 9318399
• Report Number: 1118880-2019-00317
• Device Sequence Number: 2373364
• Product Code: DYB
• UDI-Device Identifier: 00389701007489
• UDI-Public: 00389701007489
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K954234
• 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): 11/13/2019

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: 12/31/2021
• Device Model Number: N/A
• Device Catalogue Number: RSS702
• Device Lot Number: XH24
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/16/2019
• Supplement Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 12/04/2019
• 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: 7MMX60MM IN PACT ADMIRAL DRUG ELATING BALLOON; 7MMX80MM IN PACT ADMIRAL DRUG ELATING BALLOON; B.S. 7MMX2CM PERIPHERAL CUTTING BALLOON
• Patient Age: 70 YR
• Patient Weight: 93