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

Model Number M001314151

Device Problem Detachment Of Device Component (1104)

Patient Problems Nausea (1970); Vomiting (2144); Dizziness (2194); Device Embedded In Tissue or Plaque (3165)

Event Date 04/08/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that tip detachment occurred.A cerebral angiography procedure was conducted.An imager ii angiographic catheter was advanced to the left vertebral artery and contrast was injected through the catheter.The catheter was then removed from the patient and it was noted approximately 2cm of the catheter tip had detached inside the patient.The physician attempted to retrieve the tip using a gooseneck snare; however, this was unsuccessful.The detached tip was retained in the patient's left vertebral artery.The patient presented symptoms of dizziness, nausea and vomiting, but no dysfunction was found.It was reported the patient was in stable condition.

• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5008795
• MDR Text Key: 23215840
• Report Number: 2134265-2015-05596
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K120893
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Report Date: 07/30/2015

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: 06/30/2015
• Device Model Number: M001314151
• Device Catalogue Number: 31-415
• Device Lot Number: 0000087847
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR