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 Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/20/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tip detachment occurred inside the patient.The target lesion was located in the iliac artery.An imager ii angiographic catheter was selected for use during a superficial femoral artery intervention.However, the tip of the catheter broke off inside the patient and in the process of snaring, the tip was cut into half.The largest portion of the catheter tip was removed, while a small portion became embedded in the iliac arterial wall.Subsequently, a stent was used to trap the embedded tip in the iliac portion.No patient complications were reported.
Event or Problem Description
It was reported that tip detachment occurred inside the patient.The target lesion was located in the iliac artery.An imager ii angiographic catheter was selected for use during a superficial femoral artery intervention.However, the tip of the catheter broke off inside the patient and in the process of snaring, the tip was cut into half.The largest portion of the catheter tip was removed, while a small portion became embedded in the iliac arterial wall.Subsequently, a stent was used to trap the embedded tip in the iliac portion.No patient complications were reported.It was futher reported that, the tip initially broke off in left common femoral artery before reaching lesion.It was captured through snaring and then broke it again trying to pull separated tip into the sheath.A 6fr sheath was used during the second break.Approximately 5mm length remained in the patient.The patient was reported to be ok and was discharged the same day.

• 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: 9565694
• Report Number: 2134265-2019-16482
• Device Sequence Number: 2197475
• Product Code: DQO
• UDI-Device Identifier: 08714729355410
• UDI-Public: 08714729355410
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K121694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2020

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: 06/13/2020
• Device Model Number: 38270
• Device Catalogue Number: 38270
• Device Lot Number: 0000132447
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/20/2019
• Supplement Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 01/08/2020
• Supplement Report FDA Received Date: 02/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 92484513-FA
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention