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

Model Number	38270
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Bradycardia (1751); Death (1802); Low Blood Pressure/ Hypotension (1914); Respiratory Distress (2045); Coma (2417); Device Embedded In Tissue or Plaque (3165)
Date of Event	10/18/2019
Type of Reportable Event	Death
Event or Problem 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.
Event or Problem 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.It was further reported that the patient sank into the coma when the physician tried to snare the device fragment.
Event or Problem Description
It was reported that catheter tip was fractured and detachment encountered.A ii/5/bern/100/038 bx5 imager ii angiographic 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.It was further reported that the patient sank into the coma when the physician tried to snare the device fragment.It was further reported that the patient died.

• Brand Name: IMAGER II ANGIOGRAPHIC CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9265933
• Report Number: 2134265-2019-13161
• Device Sequence Number: 2498501
• Product Code: DQO
• UDI-Device Identifier: 08714729354871
• UDI-Public: 08714729354871
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K121694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/13/2019

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: 09/12/2020
• Device Model Number: 38270
• Device Catalogue Number: 38270
• Device Lot Number: 0000134600
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/22/2019
• Supplement Date Received by Manufacturer: 11/14/2019; 12/10/2019
• Initial Report FDA Received Date: 11/01/2019
• Supplement Report FDA Received Date: 12/02/2019; 12/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Life Threatening; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 50