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

Model Number 38275

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/02/2022

Event Type  malfunction  

Event Description

It was reported that device perforation occurred.The patient presented with an aneurysm in the internal iliac artery.The imager ii angiographic catheter was used for a coiling hypogastric procedure.During the procedure, a 0.035 interlock diamond 6mm coil would not attach.The device was removed 100% intact with traditional pull back.A second interlock coil of the same size was successfully inserted however, upon removal of the imager, it was noted that the coil had perforated through the the sidewall of the catheter at the proximal tip before the angled shape.The procedure was completed with this device.No patient complications were reported.

• 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
• Manufacturer (Section G): TELEFLEX MEDICAL; unit 7 8 and 9; annacotty ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15495670
• MDR Text Key: 304919355
• Report Number: 2124215-2022-36580
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 08714729404439
• UDI-Public: 08714729404439
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120893
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2022
• Device Model Number: 38275
• Device Catalogue Number: 38275
• Device Lot Number: 0000154753
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/02/2022
• Initial Date FDA Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female