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

Model Number	38275
Medical Device Problem Codes	Entrapment of Device (1212); Material Puncture/Hole (1504); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/09/2019
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
Adverse event/product problem, outcomes attrib to adv event, describe event or problem, and type of reportable event were corrected.
Event or Problem 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
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8267758
• Report Number: 2134265-2019-00234
• Device Sequence Number: 11292780
• Product Code: DQO
• UDI-Device Identifier: 08714729404439
• UDI-Public: 08714729404439
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K120893
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 01/09/2019
• Supplement Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 01/22/2019
• Supplement Report FDA Received Date: 01/24/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention