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

Model Number 38270

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 07/16/2020

Event Type  Injury  

Event Description

It was reported that tip detachment occurred.A 5f sim1 imager ii angiographic catheter was selected for a uterine artery fibroid embolization procedure.The catheter tip detached while advancing inside the patient.No resistance was encountered during use and the anatomy was not tortuous.The detached tip was snared and the procedure was completed with another of the same device.There was no patient complications reported and the patient was stable post-procedure.

• 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): TFX ENGINEERING LIMITED T/A; unit 7 8 and 9; annacotty li ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10369119
• MDR Text Key: 201744259
• Report Number: 2134265-2020-10540
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 08714729355151
• UDI-Public: 08714729355151
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K121694
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 08/05/2020

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: 09/25/2020
• Device Model Number: 38270
• Device Catalogue Number: 38270
• Device Lot Number: 0000134902
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/16/2020
• Initial Date FDA Received: 08/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 92484513-FA
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 56