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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device was not returned 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.(b)(4).
Event or Problem Description
Terumo medical received a user facility medwatch report # (b)(4).The event description states: "the patient was undergoing a right superficial femoral artery stenting and right femoral popliteal and distal vessel arteriograms.It was noted at the end of the procedure that the terumo fr.4 pinnacle introducer sheath had broken off.X-ray revealed the tip if the terumo fr.4 introducer sheath remained in the subcutaneous tissue in the left groin.The surgeon determined that in order to get the small fragment out a cut down would have to be performed and this would not benefit the patient.The surgeon decided to leave the tip in, as it would not cause harm to the patient".Additional information was received on may 1, 2018.The patient's condition was reported to be stable, and was discharged the following day.A small tip of the introducer sheath had broken off.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.With no return of the actual device, the exact cause of the reported event cannot be definitively determined based on the available information.

• 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: 8599495
• Report Number: 1118880-2019-00109
• Device Sequence Number: 11265241
• Product Code: DYB
• UDI-Device Identifier: 00389701010762
• UDI-Public: 00389701010762
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2019

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: 06/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 70-4160
• Device Lot Number: XA02
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/26/2019
• Supplement Date Received by Manufacturer: 05/31/2019
• Initial Report FDA Received Date: 05/10/2019
• Supplement Report FDA Received Date: 06/04/2019
• 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
• Patient Age: 75 YR
• Patient Weight: 81