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	No Consequences Or Impact To Patient (2199)
Date of Event	10/28/2019
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.
Event or Problem Description
The user facility reported that a boston scientific 6 mm x 20 mm peripheral cutting balloon was delivered through a 6 fr 25 cm pinnacle sheath to right popliteal artery.Popliteal artery was treated with balloon angioplasty.Procedure was completed successfully and the patient was in stable condition.When the sheath was pulled post procedure, it was noticed that the sheath was cut longitudinally along the sheath shaft.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation results.The evaluation of the actual device could not be conducted due to the device not being returned.With no device return, the exact cause of the reported event cannot be definitively determined based on the available information.
Additional Manufacturer Narrative
This report is being submitted as follow up no.2 provide the device returned date in the d10 section, to update the h3 section and to provide the completed investigation results.One 6fr glidesheath slender sheath was received for product evaluation.Visual inspection revealed a longitudinal tear was seen on the sheath starting 14.85 cm from the hub and continued down to the tip.A kink was observed at the hub and 16.7 cm from the hub.No other damage or gross anomalies were observed on the sheath.Based on the provided information and investigation results there is no evidence that this event was related to a device defect or malfunction.Based on the investigation results, it is likely that the blades on the cutting balloon created the tear in the sheath longitudinally.However, the exact cause of the reported event cannot be definitely 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: 9353646
• Report Number: 1118880-2019-00323
• Device Sequence Number: 2237691
• Product Code: DYB
• UDI-Device Identifier: 00389701007717
• UDI-Public: 00389701007717
• 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,Followup
• Report Date (Section B): 11/21/2019

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: 08/31/2021
• Device Model Number: N/A
• Device Catalogue Number: RSS606
• Device Lot Number: XD20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Initial Date Received by Manufacturer: 10/28/2019
• Supplement Date Received by Manufacturer: 01/13/2020; 01/15/2020
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 01/13/2020; 01/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 101