MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION PINNACLE DESTINATION PERIPHERAL 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	09/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device has been returned to the manufacturing facility 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 when the destination package was opened, the ccv fell out of the package and on to the floor.The ccv and sheath were not screwed together.The product never touched the patient, however the product was opened and remained clean.The procedure outcome was successful, and the patient condition was good.There were no other equipment or devices being used with the reported product.A second sheath was opened.Additional information was received on september 18, 2018.The procedure was a lower extremity angiogram and intervention.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation.(b)(4).One 5fr destination device was returned for product evaluation.The sheath hub returned separate from the crosscut valve assembly.Visual inspection of the device was carried out.No anomalies were noted with either the threads on the sheath hub or the inner lumen of the luer of the crosscut valve assembly.The crosscut valve assembly and the sheath hub were then mated securely, and tensile force was applied to the valve while it remained attached to the sheath hub.The crosscut valve assembly did not detach from the sheath hub while force was applied.No other anomalies were noted.The destination guiding sheath ifu states: "ensure that the valve and the sheath are tightly connected." there is no evidence that this event was related to a device defect or malfunction.Based off the investigation of the actual device, it is likely that transverse forces loosened the valve post manufacturing.However, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 7905764
• Report Number: 1118880-2018-00135
• Device Sequence Number: 1653874
• Product Code: DYB
• UDI-Device Identifier: 00389701008912
• UDI-Public: 00389701008912
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K081046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2018

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: 12/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 54-54501
• Device Lot Number: WH18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2018
• Initial Date Received by Manufacturer: 09/10/2018
• Supplement Date Received by Manufacturer: 10/01/2018
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 10/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1