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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN UNKNOWN_NEUROVASCULAR_PRODUCT; CATHETER, BALLOON TYPE
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BOSTON SCIENTIFIC - MINN UNKNOWN_NEUROVASCULAR_PRODUCT; CATHETER, BALLOON TYPE Back to Search Results
Catalog Number UNK_NEU
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stroke/CVA (1770); Feeding Problem (1850); Loss of consciousness (2418); Insufficient Information (4580)
Event Date 02/03/2022
Event Type  Injury  
Event Description
It was reported during the procedure the stent couldn't deploy.Post-procedure magnetic resonance imaging (mri) showed extensive infection.The patient¿s level of consciousness ( jcs) was 1-3.The physician did not know the causal relationship with the subject balloon or another device(s).Gooseneck snare was used as a medical intervention.The procedure was completed successfully.
 
Manufacturer Narrative
This is 4 of 6 reports (4th mdr).
 
Event Description
It was reported during the procedure the stent (subject device) couldn't deploy.Post-procedure magnetic resonance imaging (mri) showed extensive infection (ischemic stroke).The patient¿s level of consciousness ( jcs) was 1-3 and unable to eat.The physician did not know the causal relationship with subject surpass or another device(s).Gooseneck snare was used as a medical intervention.The procedure was completed successfully.
 
Manufacturer Narrative
B5 executive summary ¿ updated.F10/h6 clinical signs code grid ¿ updated.D9 product available to stryker ¿ updated.H3 reason for no evaluation -updated.H3 reason code ¿ other ¿ added h3 other text : the device is not available to the manufacturer.
 
Manufacturer Narrative
Based on the results of the dhr (device history review) review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.The device history record review could not be completed because the lot number is unknown.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.The risk of the reported event is covered in the device directions for use (dfu).The reported event was unable to be confirmed and it cannot be confirmed if the device met specification, as the device was not returned.Based upon medical review, the harms observed in the complaint is anticipated in nature as a potential adverse event from these type of procedures and is documented as anticipated as per the device dfu/risk assessment, therefore an assignable cause of anticipated procedural complication was assigned to the as reported ¿patient stroke¿, ¿patient complications¿ and ¿patient abnormal imaging finding¿.
 
Event Description
It was reported during the procedure the stent (subject device) couldn't deploy.Post-procedure magnetic resonance imaging (mri) showed extensive infection (ischemic stroke).The patient¿s level of consciousness ( jcs) was 1-3 and unable to eat.The physician did not know the causal relationship with subject surpass or another device(s).Gooseneck snare was used as a medical intervention.The procedure was completed successfully.
 
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Brand Name
UNKNOWN_NEUROVASCULAR_PRODUCT
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 Key13648134
MDR Text Key289762724
Report Number3008853977-2022-00011
Device Sequence Number1
Product Code GBA
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
H050001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 05/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK_NEU
Was Device Available for Evaluation? No
Date Returned to Manufacturer02/28/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/23/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
CAROTID WALLSTENT (NO-STRYKER MANUFACTURER); CAT5 (STRYKER MANUFACTURER); CHIKAI GW (NO-STRYKER MANUFACTURER); GUIDING SHEATH (NO-STRYKER MANUFACTURER); OFFSET CATHETER (STRYKER MANUFACTURER); THREE SURPASS STREAM LINE (STRYKER MANUFACTURER)
Patient Outcome(s) Required Intervention; Other;
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