MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION PINNACLE PRECISION ACCESS SYSTEM; INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device has been received 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 number combination was conducted with no relevant findings.A search of the complaint file did not find any other report with the involved product code/lot number combination.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.
Event or Problem Description
The user facility reported that upon removal of the sheath the dilator snapped off.All pieces were retrieved and no adverse event or harm was done to the patient.The doctor was the person who removed it.The patient is stable.The procedure outcome was normal.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to report the device evaluation.One used 5fr ik precision dilator was received for product analysis.After decontamination, the returned dilator was subjected to visual analysis.The dilator was returned in two portions: the proximal gray hub and the main body of the dilator tubing.There was what appeared on the gross level to be a clean break at the junction there the hub and the dilator tubing met.Microscopy was needed to further analyze the type of fracture that occurred.A projected view of the fracture found some deformation at the fracture site.A portion of the material appeared to have deform and protruded from the flat surface.This deformation would not have been caused by cutting the device in two with a sharp edge.The fracture site at the main body of the device had more significant deformation that warped the inner diameter of the tubing and had a rough appearance.Based on the microscopic analysis the fracture was likely caused by tensile forces that caused the material to protrude from the main plane of the fracture.The cause of the tensile force may have been related to the use of the device where either with a clamp or through the dilator being caught on another structural anomaly such as calcium deposit sufficient tensile forces were applied.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.
Additional Manufacturer Narrative
This report is being submitted as follow up no.2 to provide the completed investigation results.There is no evidence that this event was related to a device defect or malfunction.The exact cause of the reported event cannot be definitively determined.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

• Brand Name: PINNACLE PRECISION ACCESS SYSTEM
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 6715119
• Report Number: 1118880-2017-00046
• Device Sequence Number: 11074228
• Product Code: DYB
• UDI-Device Identifier: 00389701010779
• UDI-Public: (01)00389701010779(17)190630(10)VA25
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K111606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/14/2017

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: 06/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 70-5160
• Device Lot Number: VA25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/16/2017
• Supplement Date Received by Manufacturer: 07/21/2017; 09/06/2017
• Initial Report FDA Received Date: 07/14/2017
• Supplement Report FDA Received Date: 08/01/2017; 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 06 MO
• Patient Weight: 6