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 Inflammation (1932); Reaction (2414)

Event Date 06/25/2015

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 an inflammatory reaction occurred.A mach1 guide catheter was selected to treat an aneurysm.After the embolization of an intracranial aneurysm on a case of a granulomatous meningitis, patient had an inflammatory reaction.Furthermore, regression of motor deficit was observed with the patient under corticosteroid therapy as medical intervention.

Manufacturer Narrative

Updated: manufacturing site name.(b)(4).

Event Description

It was reported that an inflammatory reaction occurred.A mach1 guide catheter was selected to treat an aneurysm.After the embolization of an intracranial aneurysm on a case of a granulomatous meningitis, patient had an inflammatory reaction.Furthermore, regression of motor deficit was observed with the patient under corticosteroid therapy as medical intervention.

• 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: 5081198
• MDR Text Key: 25991996
• Report Number: 2134265-2015-06256
• 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: Health Professional
• Type of Report: Followup
• Report Date: 08/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: M001197380
• Device Catalogue Number: 19-738
• Device Lot Number: 0050875292
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2015
• 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