MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN FG GATEWAY OTW JP 3.00MM X 12MM; CATHETER, BALLOON TYPE

Catalog Number M0032072012300

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

Patient Problem Vascular Dissection (3160)

Event Date 01/15/2015

Event Type  Injury  

Event Description

It was reported a case where the patient had two lesions in the left ica (internal carotid artery).The strategy was to perform percutaneous transluminal angioplasty (pta) and stent the distal lesion, and perform pta for the proximal lesion.Following angioplasty of the proximal lesion using two different size balloon catheters, the distal lesion was dilated with the second balloon catheter (subject device).When dilating the distal lesion, a dissection was noted at the lesion, and the physician¿s opinion of the cause was pta.Stenting was attempted, but the stent was unable to reach the distal lesion, and was deployed in the proximal lesion, which was intended.No treatment was performed for the dissection.The patient condition immediately after the procedure as a result of these issues was stable, and the current patient condition is fine.

Manufacturer Narrative

Additional mfg narrative: the subject device was not returned; therefore, an analysis could not be performed.The device history record review confirms that the device met all material, assembly and performance specifications.Because the reported event is a known physiological effect of the procedure noted with the directions for use and/or device labeling, a cause of anticipated procedural complication was assigned to this event.

Event Description

It was reported a case where the patient had two lesions in the left ica (internal carotid artery).The strategy was to perform percutaneous transluminal angioplasty (pta) and stent the distal lesion, and perform pta for the proximal lesion.Following angioplasty of the proximal lesion using two different size balloon catheters, the distal lesion was dilated with the second balloon catheter (subject device).When dilating the distal lesion, a dissection was noted at the lesion.Stenting was attempted, but the stent was unable to reach the distal lesion, and was deployed in the proximal lesion.No treatment was performed for the dissection.No additional information is available.

Manufacturer Narrative

The subject device will not be returned because it was disposed at the hospital.

• Brand Name: FG GATEWAY OTW JP 3.00MM 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: kathleen shin ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 4642878
• MDR Text Key: 5786506
• Report Number: 3008853977-2015-00151
• Device Sequence Number: 1
• Product Code: GBA
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/24/2016
• Device Catalogue Number: M0032072012300
• Device Lot Number: 16564563
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2013
• 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: 67 YR