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

Model Number	38265
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)
Date of Event	12/06/2019
Type of Reportable Event	Serious Injury
Event or Problem 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 or Problem 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.
Additional 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
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9474085
• Report Number: 2134265-2019-15801
• Device Sequence Number: 19495178
• Product Code: DQO
• UDI-Device Identifier: 08714729355892
• UDI-Public: 08714729355892
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K120893
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2020

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: 06/26/2020
• Device Model Number: 38265
• Device Catalogue Number: 38265
• Device Lot Number: 0000132823
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 01/12/2020
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 01/24/2020
• 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: Other