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

Model Number 38275

Device Problems Entrapment of Device (1212); Material Puncture/Hole (1504); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2019

Event Type  Injury  

Event Description

It was reported that difficulty in catheter removal and a hole in catheter occurred.The target lesion was located in a moderately tortuous hypogastric artery.An imager ii angiographic catheter was selected for use.During procedure, catheter would not release from the interlock 35 coil pack after deployment.The procedure was completed with original device.The devices were removed by using a buddy wire and an another diagnostic catheter to hold the coil pack in place.No additional intervention was required for device removal.Upon final removal, it was noted that there was a large hole in the bern of the imager ii angiographic catheter.No patient complications were reported.

Manufacturer Narrative

Adverse event/product problem, outcomes attrib to adv event, describe event or problem, and type of reportable event were corrected.

Event Description

It was reported that difficulty in catheter removal and a hole in catheter occurred.The target lesion was located in a moderately tortuous hypogastric artery.An imager ii angiographic catheter was selected for use.During procedure, catheter would not release from the interlock 35 coil pack after deployment.The procedure was completed with original device.The devices were removed by using a buddy wire and an another diagnostic catheter to hold the coil pack in place.No additional intervention was required for device removal.Upon final removal, it was noted that there was a large hole in the bern of the imager ii angiographic catheter.No patient complications were reported.It was corrected that additional device use of a buddy wire and additional diagnostic catheter were required to hold the coil pack in place in order to remove the imager catheter.

• 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: 8267758
• MDR Text Key: 133765074
• Report Number: 2134265-2019-00234
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 08714729404439
• UDI-Public: 08714729404439
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/24/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2020
• Device Model Number: 38275
• Device Catalogue Number: 38275
• Device Lot Number: 0000135444
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/09/2019
• Initial Date FDA Received: 01/22/2019
• Supplement Dates Manufacturer Received: 01/09/2019
• Supplement Dates FDA Received: 01/24/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention