MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION IMPULSE GUIDE CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 7965

Device Problem Difficult to Advance (2920)

Patient Problems Stroke/CVA (1770); Muscle Weakness (1967); Brain Injury (2219)

Event Date 06/09/2022

Event Type  Injury  

Manufacturer Narrative

Mfg address line 1 = (b)(4).

Event Description

It was reported that an embolic stroke occurred resulting in expressive aphasia.On (b)(6) 2022, an impluse diagnostic guide catheter was selected for use in a coronary intervention procedure.The impluse took 4 mins to cross the valve.Post procedure, within the same month as the initial procedure, the patient experienced an embolic stroke requiring hospital treatment.The patient experienced memory loss and left side weakness post stroke.No further patient complications were reported.

• Brand Name: IMPULSE GUIDE CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): AVAILMED S.A. DE C.V.; col. cd. industrial; tijuana, baja california 22444 ; MX 22444
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15258674
• MDR Text Key: 298217001
• Report Number: 2134265-2022-08594
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 7965
• Device Catalogue Number: 7965
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female