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	Blood Loss (2597)
Date of Event	01/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device has been 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.
Event or Problem Description
The user facility reported when the physician was removing the ik sheath from the right femoral artery, the wire was shredded.Radial approach was performed and successful percutaneous coronary intervention was performed.The blood loss was less than 250cc's.The patient was in stable condition.There were no other devices or equipment used with the reported product.Additional information was received on january 18, 2019.The wire unraveled.The procedure was completed.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to update and to provide the completed investigation results.One 0.021" guidewire was returned for product evaluation.No other accessory components were returned.Visual inspection revealed that the guidewire was returned into two pieces; however, they were still connected via the unraveled coil.The stiff end measured to be 0.0200" using a sliding gauge which is within the specification limits of 0.0205" ± 0.0005.Under microscopy of the unraveled sections and points of fracture were visualized, the fracture point appeared to be bluntly cut.There is no evidence that this event was related to a device defect or malfunction.Based on the investigation results, it is likely that the guidewire was restricted from removal at the point where the coil starts to unravel from the distal end.However, 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: 8285475
• Report Number: 1118880-2019-00007
• Device Sequence Number: 16548460
• Product Code: DYB
• UDI-Device Identifier: 00389701010793
• UDI-Public: 00389701010793
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 01/29/2019

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: 01/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 70-7160
• Device Lot Number: WK08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Initial Date Received by Manufacturer: 01/15/2019
• Supplement Date Received by Manufacturer: 03/04/2019
• Initial Report FDA Received Date: 01/29/2019
• Supplement Report FDA Received Date: 03/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 68