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 Codes	Foreign Body In Patient (2687); Thrombosis/Thrombus (4440)
Date of Event	07/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation - risk manager.(b)(4).The actual device was not available; therefore, the actual device will not be 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 number combination was conducted with no findings.
Event or Problem Description
Terumo medical received an fda medwatch report # mw5112081.The event description states: "patient required a inari thrombectomy on (b)(6) 2022 for extensive pulmonary emboli in bilateral amin pulmonary arteries.On (b)(6) on ctap metallic foreign body was seen in the right external iliac vein- icu notes state "cardiology aware discussed with patient that piece of wire broke off in thrombus." per cardiology, will keep patient on life long noac to avoid future thrombus around the wire.Patient expired on (b)(6) 2022 after going into pea arrest.Physician interview occurred and he does not believe this event caused/contributed to patient's death.Fda safety report id# (b)(4)." additional information was received on 09/30/2022: the initial procedure was an inari thrombectomy and it was performed on (b)(6) 2022.The date of the patient's death was (b)(6) 2022.The physician stated that he did not feel that the wire contributed to the patient's death because the patient already had blood clots prior to the event.The patient had a history of obesity and marijuana dependency.Diagnosed (dx) in hospital with bilateral pulmonary embolism's (p.E.'s).The patient (pt) was 29 years old and denied history (hx) of hypertension (htn), or cardiac issues.The patient (pt) stated his family has history (hx) of blood clots and cardiac issues.His sister had blood clots.Computed tomograpy angiography (cta) in hospital showed bilateral pulmonary embolism's (pe's) for the patient (pt).Additional information was received on 03 oct 2022: the case was an emergent case that the team was called into perform.
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.The complaint cannot be confirmed since the device was not available for evaluation.The exact root cause cannot be confirmed.The likely root cause is the wire became 'caught' in the vessel.The device history record (dhr) review determined that the device was in a conforming state when released from terumo control.There is no indication that any manufacturing issues may have led to this event.Currently no action is recommended since this risk evaluation is within the predetermined limits in the failure mode & effects analysis (fmea).

• Brand Name: PINNACLE PRECISION ACCESS SYSTEM
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer (Section G): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer Contact: gina digioia ; 950 elkton blvd.; elkton, MD 21921 ; 6402040886
• MDR Report Key: 15676797
• Report Number: 1118880-2022-00081
• Device Sequence Number: 12367460
• Product Code: DYB
• UDI-Device Identifier: 00389701010793
• UDI-Public: 00389701010793
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K111606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2022

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: 11/01/2024
• Device Model Number: N/A
• Device Catalogue Number: 70-7160
• Device Lot Number: 0000196106
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2022
• Supplement Date Received by Manufacturer: 10/27/2022
• Initial Report FDA Received Date: 10/26/2022
• Supplement Report FDA Received Date: 11/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 29 YR
• Patient Sex: Male
• Patient Race: American Indian Or Alaskan Native