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

Catalog Number	70-6160
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/24/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results - is based on evaluation of the user facility information & the returned sample; is based on evaluation of the retention samples from the reported and surrounding lots.Conclusions - is based on the evaluation of the user facility information & the returned sample; is based on evaluation of the retention samples from the reported and surrounding lots.The needle and wire were returned to the manufacturer for evaluation.The needle revealed no visual defects.The tip of the wire was noted to be missing and the over-coil was coming off the core wire at the distal end of the wire.The proximal end of the wire was able to pass through the needle.An evaluation of the reported and surrounding lots manufactured was conducted.A visual inspection revealed no visual defects.Wire in needle fit, needle id, and wire od confirmed the products met manufacturing specifications.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.There is no evidence that this event was related to a device defect or malfunction.The retention samples were found to be normal product.An exact cause of the reported event cannot be definitively determined based on the available information.All available information has been forwarded to the manufacturing facility for appropriate tracking, trending and follow up.
Event or Problem Description
The user facility reported wire separation.Follow up communication with the user facility confirmed the following information: the wire separated from itself; this event occurred prior to procedure; and the patient was not involved.

• 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: 6122470
• Report Number: 1118880-2016-00261
• Device Sequence Number: 13542618
• Product Code: DYB
• UDI-Device Identifier: 00389701010786
• UDI-Public: 00389701010786
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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
• Report Date (Section B): 11/22/2016

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: 11/30/2018
• Device Catalogue Number: 70-6160
• Device Lot Number: UG29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2016
• Initial Report FDA Received Date: 11/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1