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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE ULTRA-SOFT¿ SV CATHETER, PERCUTANEOUS

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BOSTON SCIENTIFIC - MAPLE GROVE ULTRA-SOFT¿ SV CATHETER, PERCUTANEOUS Back to Search Results
Model Number M0013894040200
Device Problems Balloon (419); Material Rupture (1546)
Patient Problems Muscle Weakness (1967); Transient Ischemic Attack (2109)
Event Date 01/03/2018
Event Type  Injury  
Manufacturer Narrative

Age at time of event: born in (b)(6). (b)(4). Device evaluated by mfr: it is indicated that the device will not be returned for evaluation. If there is any further relevant information obtained, a supplemental medwatch will be filed. (b)(4).

 
Event Description

It was reported that balloon rupture and subsequent complications occurred. The target lesion was located in the right carotid artery. A filterwire ez was advanced followed by the deployment of a 7x40 mm non-bsc stent. A 4. 0 mm x 20 mm x 143 cm ultra-soft¿ sv was then selected and advanced without problems for post-dilation. During inflation, the balloon ruptured at approximately 8atms. The balloon did not fragment and was removed intact. The patient immediately presented with a neurological symptom with a pronounced arm-hugging hemiparesis on the left, a left palate weakness, and a rightward gaze. The patient was neurologically unremarkable prior to this event. The filter was completely free of thrombus. The procedure was completed normally and the result, based on the stent, was good. The patient was treated neurologically right after the intervention. One day post-procedure, the patient's neurological symptoms declined, leaving a latent hemiparesis, and the patient was discharged. At the time of discharge there were still some symptoms of the disease. The physician believes the symptoms of the patient were most likely due to an air embolism.

 
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Brand NameULTRA-SOFT¿ SV
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key7251735
MDR Text Key99351932
Report Number2134265-2018-00422
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
PMA/PMN NumberK050389
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 01/11/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/08/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/02/2020
Device MODEL NumberM0013894040200
Device Catalogue Number40-4020
Device LOT Number21209871
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/11/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/03/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/08/2018 Patient Sequence Number: 1
Treatment
7MM CORDIS PRECISE STENT; FILTERWIRE EZ
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