MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE IMAGER II ANGIOGRAPHIC CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number M001314671

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528)

Patient Problems Embolism (1829); Device Embedded In Tissue or Plaque (3165)

Event Date 04/12/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that tip detachment occurred.An imager ii angiographic catheter was selected for a vascular procedure.During the procedure, it was noted that the tip of the catheter ruptured inside the patient's body and was impossible to remove.The patient remains hospitalized for observation.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that the device was selected for a hepatic intra-arterial chemoembolization.During withdrawal of the guidewire, the catheter fractured.Embolization was noted on the branch of the right internal pudendal artery due to the detached fragment.

• Brand Name: IMAGER II ANGIOGRAPHIC CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer (Section G): TFX ENGINEERING LIMITED T/A; estate; limerick
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7462452
• MDR Text Key: 106583041
• Report Number: 2134265-2018-03728
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K120893
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: M001314671
• Device Catalogue Number: 31-467
• Device Lot Number: 0000118462
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2016
• 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): Hospitalization