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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CHARGER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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BOSTON SCIENTIFIC CORPORATION CHARGER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 24681
Device Problems Leak/Splash (1354); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 12/21/2020
Event Type  Injury  
Manufacturer Narrative
Age at time of event: under 65 years.
 
Event Description
It was reported that there was a leak, difficulty removing the device, and unretrieved device fragments left in the patient. A 12mm x 60mm x 75cm charger balloon catheter was selected for use in a left upper arm balloon angioplasty and stenting procedure. The left upper subclavian vein had two previously placed stents. One stent appeared to have been placed through the struts of the other. Some fractures were present with exposed nitinol struts. Upon inflation and deflation in the area of the fractured stent, blood was noted in the inflation device, which indicated a pin hole or tear in the balloon material. Resistance was felt upon removal. Some balloon material remained on the stent strut. A second wire was placed next to the first and used to complete the case. A 12mm x 60mm venous wallstent was placed over the second wire and post dilated with a 10mm x 40mm balloon, which opened the in-stent restenosis and trapped any balloon material behind the stent. Angiographic and intravascular ultrasound (ivus) imaging proved to be widely patent. Both the first and second wires were removed without incident.
 
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Brand NameCHARGER
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key11155458
MDR Text Key226283299
Report Number2134265-2020-18884
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112697
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 01/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number24681
Device Catalogue Number24681
Device Lot Number0026283066
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 Received12/21/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/02/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/12/2021 Patient Sequence Number: 1
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