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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION IMAGER II ANGIOGRAPHIC CATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC

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BOSTON SCIENTIFIC CORPORATION IMAGER II ANGIOGRAPHIC CATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Model Number 38270
Device Problem Detachment of Device or Device Component (2907)
Patient Problems Bradycardia (1751); Death (1802); Low Blood Pressure/ Hypotension (1914); Respiratory Distress (2045); Coma (2417); Device Embedded In Tissue or Plaque (3165)
Event Date 10/18/2019
Event Type  Death  
Event Description
It was reported that catheter tip was fractured and detachment encountered. A ii/5/bern/100/038 bx5 imager ii angiograpic catheter was selected for use in the internal carotid artery. However, during the procedure, it was noted that the tip of the catheter was fractured and detached. The physician tried to withdraw the fractured catheter at once but failed. The length of the catheter that remained in the patient's body was 2. 8cm. The physician tried to remove the fractured part with a snare but failed. There were no patient complications as this time and the patient was stable. Approximately 5 hours after device use, the patient experienced decreased respiratory heart rate, low blood pressure, and was on assisted breathing with upper tracheal intubation. After rescue, the patient was temporarily stable and was transferred to icu 30 minutes later. The patient was transferred to other hospital.
 
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Brand NameIMAGER II ANGIOGRAPHIC CATHETER
Type of DeviceCATHETER, INTRAVASCULAR, DIAGNOSTIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
TELEFLEX MEDICAL
unit 7 8 and 9
annacotty li
EI
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key9265933
MDR Text Key164615448
Report Number2134265-2019-13161
Device Sequence Number1
Product Code DQO
UDI-Device Identifier08714729354871
UDI-Public08714729354871
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K121694
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/12/2020
Device Model Number38270
Device Catalogue Number38270
Device Lot Number0000134600
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/10/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/12/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/01/2019 Patient Sequence Number: 1
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