MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN GATEWAY OTW 2.0MM X 15MM - CE; CATHETER, BALLOON TYPE

Catalog Number M0032072415200

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

Patient Problem Vascular Dissection (3160)

Event Date 09/28/2022

Event Type  Injury  

Manufacturer Narrative

The device is not available to the manufacturer.

Event Description

It was reported that following balloon dilatation with the subject balloon in a patient with left m2 stenosis in situ, vascular intimal tear was noticed.So the physician deployed a stent.Patient is doing fine.No other clinical consequences were reported to the patient due to this event.

Event Description

It was reported that following balloon dilatation with the subject balloon in a patient with left m2 stenosis in situ, vascular intimal tear was noticed.So the physician deployed a stent.Patient is doing fine.No other clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

H4 manufacturing date ¿ added.D4 expiration date - added.Based on the results of the device history record (dhr) review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.The subject device is not available; therefore, visual testing as well as functional testing cannot be performed.The reported event is covered in the device directions for use (dfu) as an anticipated outcome as part of these procedures.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.It was reported that after the acute thrombectomy case the operator found m2 stenosis in situ, so used cat6 to do aspiration and then used gateway 2.0*15 balloon to dilate.After that the vascular intima tearing(possibly related to the balloon dilation) was noticed so decided to deploy a stent.As the risk of vessel dissection's is outlined in the dfu, as unanticipated complication associated with these type of procedures, and there is no device related root cause, an assignable cause of anticipated procedural complication will be assigned to this complaint 'patient vessel dissection'.

• Brand Name: GATEWAY OTW 2.0MM X 15MM - CE
• 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: 15656855
• MDR Text Key: 302248906
• Report Number: 3008853977-2022-00053
• Device Sequence Number: 1
• Product Code: GBA
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: M0032072415200
• Device Lot Number: 28712863
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2022
• 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
• Treatment: 6F ENVOY CATHETER (CODMAN NEURO); CAT6 CATHETER (STRYKER); SYNCHRO2 GUIDEWIRE (STRYKER)
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 50 KG