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

Model Number 38265

Device Problem Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)

Event Date 12/06/2019

Event Type  Injury  

Event Description

It was reported that tip detachment occurred and remained inside the patient.The target lesion was located in the lung artery, an imager diagnostic catheter was selected to use.However, during lower extremity vein agiography the tip of the device detached in the lesion.The physician attempted to snare the tip but retrieval was unsuccessful.No patient complications were reported and the patient's status was stable.

Event Description

It was reported that tip detachment occurred and remained inside the patient.The target lesion was located in the lung artery, an imager diagnostic catheter was selected to use.However, during lower extremity vein agiography the tip of the device detached in the lesion.The physician attempted to snare the tip but retrieval was unsuccessful.No patient complications were reported and the patient's status was stable.It was further reported that the tip detached during advancement and the device was completely removed by lower extremity angiography.

Manufacturer Narrative

Correction: h6 patient codes.Corrected device fragments in patient 3165 to no known consequence or impact to the patient 2199.

• Brand Name: IMAGER II ANGIOGRAPHIC CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9474085
• MDR Text Key: 170931675
• Report Number: 2134265-2019-15801
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 08714729355892
• UDI-Public: 08714729355892
• Combination Product (y/n): N
• PMA/PMN Number: K120893
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/26/2020
• Device Model Number: 38265
• Device Catalogue Number: 38265
• Device Lot Number: 0000132823
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other