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 Codes	Blood Loss (2597); Device Embedded In Tissue or Plaque (3165)
Date of Event	04/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.A review of the device history record of the product code/lot# combination was conducted with no findings.With no device return the exact cause of the reported event cannot be definitively determined based on the available information.
Event or Problem Description
The user facility reported breakage on the involved ik: precision device.The md was attempting to get access with the precision needle and wire.The patient began to lift their head and bend at the knee.The physician tried to pull back on the wire and could not.The needle was removed and the wire was still in place.Under x-ray it was noted the wire was a bit "tangled".The suggestion was made to use the dilator instead of the needle to try to safely remove the wire.The wire broke and the dilator had to be removed.The wire was still hanging out from the tract.That wire that was hanging out was gently pulled on by the physician and it also broke leaving a small portion of the wire still in the tissue tract.A second precision sheath was used to gain access.The case was completed without any other issues.The vascular surgery was consulted regarding the wire that was left in the body.Estimated blood loss was reported to be less than 250 cc.The patient was reported to be stable.The procedure was successful with the use of a second precision sheath.Additional information was received on 4/27/18.It was reported that the physician seen the patient in the office and the patient is doing fine.Vascular surgery also saw the patient and decided to leave the little bit of the wire in the tract and stated the wire would encapsulate.

• 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: 7489881
• Report Number: 1118880-2018-00034
• Device Sequence Number: 1704880
• Product Code: DYB
• UDI-Device Identifier: 00389701010779
• UDI-Public: 00389701010779
• 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
• Report Date (Section B): 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 70-5160
• Device Lot Number: WC21
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2018
• Initial Report FDA Received Date: 05/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other