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	No Code Available (3191)
Date of Event	03/23/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tip detachment occurred.An imager diagnostic catheter was selected for use.Interventional vascular therapy was to be performed because the patient had chronic occlusion in the left external iliac artery.The artery sheath was implanted through the right femoral artery, then the guidewire was advanced to the left external iliac artery through the sheath.The imager catheter was advanced to the occlusion in the left external iliac artery through the guidewire.The physician adjusted the direction of the guidewire several times, and at last, the guidewire crossed the occluded segment of the external iliac artery to left superficial femoral artery.When the physician withdrew the imager catheter, the tip of the catheter was fractured.It fell in the external iliac artery and the length was 2cm.The physician retrieved the fractured catheter using a biopsy forceps successfully.No patient complications were reported and the patient's status was stable.

• 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: 9974466
• Report Number: 2134265-2020-05251
• Device Sequence Number: 19520484
• Product Code: DQO
• UDI-Device Identifier: 08714729355168
• UDI-Public: 08714729355168
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K121694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/17/2020

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: 03/12/2021
• Device Model Number: 38270
• Device Catalogue Number: 38270
• Device Lot Number: 0000139511
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 04/17/2020
• 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: Required Intervention
• Patient Age: 59 YR