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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device consisting of one 0.021" guidewire was returned for evaluation.The guidewire was decontaminated.No other accessory components were returned with the guidewire.After decontamination, the device was subjected to visual analysis.The distal flexible tip of the guide wire showed a presence of a small bend and unraveling of the guidewire.The unraveled portion of the guidewire measured 1.756" from the distal tip nitinol core without straightening the unraveled coils.The flexible tip of the guidewire was examined further under microscopy.The unraveled coils of the guidewire had formed a knot.The distal tip of the unraveled coils was blunt and did not indicate that a tensile fracture had occurred.A review of the device history record of the product code/lot# 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# combination.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.
Event or Problem Description
The user facility reported that the wire unraveled during insertion into the needle.The patient is stable and the procedure outcome was successful.
Additional Manufacturer Narrative
This report is being submitted to provide the completed investigation.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 based on the available information.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: 6798690
• Report Number: 1118880-2017-00067
• Device Sequence Number: 13666741
• Product Code: DYB
• UDI-Device Identifier: 00389701010786
• UDI-Public: 00389701010786
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2017

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: 08/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 70-6160
• Device Lot Number: VD22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/21/2017
• Supplement Date Received by Manufacturer: 09/14/2017
• Initial Report FDA Received Date: 08/16/2017
• Supplement Report FDA Received Date: 10/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1