MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN FG GATEWAY MR JP 3.50MM X 12MM; CATHETER, BALLOON TYPE

Catalog Number M0032072112350

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/20/2018

Event Type  Injury  

Manufacturer Narrative

This is the fourth of 4 reports.Subject device is not available.

Event Description

Patient successfully underwent intracranial stenting with stent microcatheter and balloon catheters (subject device) on the internal carotid artery (ic) with stenosis rate of 80% and lesion length of 10 mm.Next day magnetic resonance imaging (mri t2) weighted image showed unknown black void on right brain.However, the same level of ct image showed no sign.According to the physician, the black void indicates metal artifact of some metal which was used in the procedure, possibly fragments of coating or a part of product components.The patient was asymptomatic.

Manufacturer Narrative

The device history record review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, physical as well as a functional testing could not be performed.While there are a number of potential causes for the reported issue, because the review of all available information failed to identify a definitive cause and because the product was not returned for analysis, the exact cause for the reported un-retrieved device fragments cannot be determined.Expiration date: added.Manufacturing date: added.

Event Description

Patient successfully underwent intracranial stenting with stent microcatheter and balloon catheters (subject device) on the internal carotid artery (ic) with stenosis rate of 80% and lesion length of 10 mm.Next day magnetic resonance imaging (mri t2) weighted image showed unknown black void on right brain.However, the same level of ct image showed no sign.According to the physician, the black void indicates metal artifact of some metal which was used in the procedure, possibly fragments of coating or a part of product components.The patient was asymptomatic.

• Brand Name: FG GATEWAY MR JP 3.50MM X 12MM
• Type of Device: CATHETER, BALLOON TYPE
• Manufacturer (Section D): BOSTON SCIENTIFIC - MINN; one scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC - MINN; one scimed place; maple grove MN 55311
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 7775639
• MDR Text Key: 116856796
• Report Number: 3008853977-2018-00040
• Device Sequence Number: 1
• Product Code: GBA
• Combination Product (y/n): N
• PMA/PMN Number: H050001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/22/2019
• Device Catalogue Number: M0032072112350
• Device Lot Number: 20101486
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2016
• 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): Other
• Patient Age: 51 YR