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

Model Number N/A

Device Problem Material Separation (1562)

Patient Problems Foreign Body In Patient (2687); Thrombosis/Thrombus (4440)

Event Date 07/02/2022

Event Type  Injury  

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 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.

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
• Type of Device: 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
• MDR Text Key: 302475696
• Report Number: 1118880-2022-00081
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00389701010793
• UDI-Public: 00389701010793
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111606
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 70-7160
• Device Lot Number: 0000196106
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 29 YR
• Patient Sex: Male
• Patient Race: American Indian Or Alaskan Native