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

Model Number 70-1160

Device Problem Break (1069)

Patient Problems Cardiac Arrest (1762); Foreign Body In Patient (2687)

Event Date 07/02/2022

Event Type  Death  

Event Description

Per notification from quality to risk mgt on 9/8/2022---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).

• Brand Name: PINNACLE PRECISION ACCESS SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; somerset NJ 08873
• MDR Report Key: 15438237
• MDR Text Key: 300168287
• Report Number: MW5112081
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/13/2022

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
• Device Operator: Health Professional
• Device Model Number: 70-1160
• Device Lot Number: 0000196106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/15/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 29 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White