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

Model Number	38275
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the catheter tip detached.An imager ii angiographic 4f catheter was selected for use in a fistuloplasty.When the catheter was removed from the brachial artery, the tip detached.There was no resistance when the catheter was removed.Surgical intervention was required to open the vessel to remove the tip.The procedure had already been completed before the tip detached.The patient was stable and no further complications were reported.
Additional Manufacturer Narrative
G1: mfr site state: (b)(6).Device eval by mfr: the returned product consisted of an imager ii catheter.25mm of tip was separated from the shaft.The separated ends appeared to be jagged as if the separation was do to tensile/ductile forces were applied.There were marks on the separated section which appeared to look like forceps imprints.A x-ray of the device was completed to see if there were any braids that were stretched.The reported tip separation was confirmed.
Event or Problem Description
It was reported that the catheter tip detached.An imager ii angiographic 4f catheter was selected for use in a fistuloplasty.When the catheter was removed from the brachial artery, the tip detached.There was no resistance when the catheter was removed.Surgical intervention was required to open the vessel to remove the tip.The procedure had already been completed before the tip detached.The patient was stable and no further complications were reported.

• 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
• Manufacturer (Section G): TELEFLEX MEDICAL; unit 7 8 and 9; annacotty ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14003904
• Report Number: 2134265-2022-03843
• Device Sequence Number: 5090140
• Product Code: DQO
• UDI-Device Identifier: 08714729404439
• UDI-Public: 08714729404439
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K120893
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2022

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: 09/22/2022
• Device Model Number: 38275
• Device Catalogue Number: 38275
• Device Lot Number: 0000154624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2022
• Supplement Date Received by Manufacturer: 04/29/2022
• Initial Report FDA Received Date: 04/04/2022
• Supplement Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female