MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE MACH1 GUIDE CATHETER; CATHETER, PERCUTANEOUS

Model Number M001197380

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Inflammation (1932)

Event Date 02/04/2015

Event Type  Injury  

Manufacturer Narrative

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 cerebral edema and an inflammatory reaction occurred.During an aneurysm embolization procedure, a mach1 guide catheter was selected.Angiography was then performed in the left internal carotid to treat an intracranial aneurysm.Patient then experienced severe headache just after the intervention.Then, thirty days later, it was reported that the patient had continuous severe headache and had trouble with memory.The magnetic resonance imaging (mri) scan showed cerebral edema and diffused contrast enhancement raising an inflammatory reaction to foreign body "granuloma type" into the catheter holder (left internal carotid).Furthermore, it was observed that the patient had dysexecutive syndrome with psychomotor retardation.Patient then underwent a corticosteroid therapy within three weeks.Patient status was okay; however, the mri still showed a little dose of contrast.

• Brand Name: MACH1 GUIDE CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer (Section G): AVAIL MEDICAL PRODUCTS INCORPORATED; 5950 nancy ridge drive; san diego CA 92121
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5111777
• MDR Text Key: 27051758
• Report Number: 2134265-2015-06645
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K020028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 09/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: M001197380
• Device Catalogue Number: 19-738
• Device Lot Number: 0050834229
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2014
• 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
• Patient Age: 30 YR