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

Model Number 38277

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/16/2020

Event Type  Injury  

Event Description

It was reported that the tip detached.An imager ii diagnostic catheter was selected for use in the lower extremity artery.During procedure, it was observed that the tip of the device was broken.The physician failed to snare the tip out.The procedure was completed with another device.The patient was stable and there are no further patient complications reported.

• Brand Name: IMAGER II
• 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 li ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9659468
• MDR Text Key: 177404354
• Report Number: 2134265-2020-00791
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 08714729736684
• UDI-Public: 08714729736684
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/08/2020
• Device Model Number: 38277
• Device Catalogue Number: 38277
• Device Lot Number: 0000132355
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2018
• 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 Outcome(s): Required Intervention