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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO MEDICAL CORP. PINNACLE SHEATH INTRODUCER, CATHETER

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TERUMO MEDICAL CORP. PINNACLE SHEATH INTRODUCER, CATHETER Back to Search Results
Lot Number RSS602
Device Problems Difficult to Remove (1528); Material Deformation (2976)
Patient Problem Foreign Body In Patient (2687)
Event Date 07/25/2022
Event Type  Injury  
Event Description
A 6f pinnacle sheath was placed in the patient's right femoral artery and the physician was trying to insert the boston scientific 5f expo williams catheter in the sheath. The physician was having issues with the engaging the artery and was having to twist to get the catheter engaged. When they panned out to look at the arteries the catheter was kinked right outside the sheath and inside the artery. When the physician tried to pull the catheter out it wouldn't come out. He didn't want to cause harm to patient so he left in and consulted a cv surgeon. The cv surgeon was able to remove in the operating room. Route: intra-arterial. Diagnosis for use: stemi. Fda safety report id# (b)(4).
 
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Brand NamePINNACLE SHEATH
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
TERUMO MEDICAL CORP.
MDR Report Key15138219
MDR Text Key297065475
Report NumberMW5111200
Device Sequence Number2
Product Code DYB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 07/28/2022
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received07/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Lot NumberRSS602
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 07/29/2022 Patient Sequence Number: 1
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