MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION DESTINATION RENAL GUIDING SHEATH; INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.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 the involved destination was inserted, and the hub was noticeably more loose and leaked more than normal.A leg angio was performed, and initial access was made via micro access, then a 5fr pinnacle was inserted.There was no patient injury or medical intervention.A percutaneous transluminal angioplasty (pta) was performed.Additional information was received on 03sept019.The patient was reported to be in stable condition.The bleeding occurred out of the sheath hub; out of the device.The bleeding stopped once the sheath hub was screwed back on.The patient was not obese.There was no hematoma noted.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation results.H6 - results - 3211 is based upon the visual inspection of the returned sample; 213 is based upon functional testing of the returned sample.One 5fr destination sheath and dilator were received for product evaluation.Visual inspection revealed damage at the distal tip of the dilator sheath.The sheath was then subjected to leak testing.The distal end of the sheath was inserted into a 12 fr balloon.The distal end of the balloon was connected to a controlled air supply system.The 3-way stopcock (3wsc) was closed, and the air pressure was increased to 4.3 psi (equivalent to 222 mmhg).The setup was submerged underwater for approximately 30 seconds.No air bubbles were observed.A dilator for investigational purposes was then inserted into the sheath.This assembly was submerged in water, and no bubbles were detected for 30 seconds.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.The investigation results verified the returned sample was of the normal product.Based on the damage observed, it is likely that the sheath was not securely tightened to the sheath hub.However, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: DESTINATION RENAL GUIDING SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 8981168
• Report Number: 1118880-2019-00237
• Device Sequence Number: 19616134
• Product Code: DYB
• UDI-Device Identifier: 00389701008936
• UDI-Public: 00389701008936
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K081045
• 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): 09/10/2019

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: 54-54503
• Device Lot Number: XD27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2019
• Initial Date Received by Manufacturer: 08/16/2019
• Supplement Date Received by Manufacturer: 08/23/2019
• Initial Report FDA Received Date: 09/10/2019
• Supplement Report FDA Received Date: 09/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR