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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ULTRA-SOFT SV; CATHETER, PERCUTANEOUS
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BOSTON SCIENTIFIC CORPORATION ULTRA-SOFT SV; CATHETER, PERCUTANEOUS Back to Search Results
Model Number 24680
Device Problems Device Markings/Labelling Problem (2911); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/21/2019
Event Type  malfunction  
Event Description
It was reported that the packaging of a device was incorrectly labeled.During a carotid stenting procedure, a 2.0 mm x 20 mm x 143 cm ultra soft sv was used and was noticed to not be identical to the size 3.0 mm x 20 mm x 143 cm ultra soft sv labeled on the package/box.The procedure was completed successfully.No patient complications were reported in relation to this event.
 
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an ultrasoft (ussv) balloon catheter inside the shelf carton/box, without the pouch.The device was bloody, and the balloon was loosely folded with contrast in the balloon and inner lumen (shaft).A tuohy was connected to the hub.Product analysis was conducted by personnel from the (b)(4) complaint investigation site (cis) and operations engineering.Based on the potential root causes identified, the box, pouch, and hub were microscopically and visually inspected.Inspection of the hub found the printed device size to be 2.0/2.0 with a batch number of 22757481 027, tip damage (flared out), and a kink in the hypotube located 41cm from the strain relief.Inspection of the rest of the device found no other damage or irregularity.The reported product mislabeled could not be confirmed via product analysis.There was no evidence of any material or manufacturing deficiencies contributing to the damage.
 
Event Description
It was reported that the packaging of a device was incorrectly labeled.During a carotid stenting procedure, a 2.0 mm x 20 mm x 143 cm ultra soft sv was used and was noticed to not be identical to the size 3.0 mm x 20 mm x 143 cm ultra soft sv labeled on the package/box.The procedure was completed successfully.No patient complications were reported in relation to this event.
 
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Brand Name
ULTRA-SOFT SV
Type of Device
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8430005
MDR Text Key139118668
Report Number2134265-2019-02490
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/09/2021
Device Model Number24680
Device Catalogue Number24680
Device Lot Number22772605
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/19/2019
Date Manufacturer Received04/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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