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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MAXFORCE CATHETER, BILIARY, DIAGNOSTIC

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BOSTON SCIENTIFIC CORPORATION MAXFORCE CATHETER, BILIARY, DIAGNOSTIC Back to Search Results
Model Number M00567340
Device Problems Material Puncture/Hole (1504); Material Rupture (1546)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/07/2021
Event Type  malfunction  
Event Description
It was reported that balloon rupture occurred. The target lesion was located in the common bile duct. A 3. 00mm x 15mm nc emerge balloon catheter was advanced over the wire for dilatation. However, during the first inflation, a hole and leak was noted. A second 3. 00mm x 15mm nc emerge balloon catheter was used for dilatation but the same problem was encountered. The procedure was completed with another of same device. There were no patient complications reported.
 
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Brand NameMAXFORCE
Type of DeviceCATHETER, BILIARY, DIAGNOSTIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORK LIMITED
cork business technology park
model farm road
cork MN
EI
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key13124911
MDR Text Key283252284
Report Number2134265-2021-16391
Device Sequence Number1
Product Code FGE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K910931
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/31/2022
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received12/31/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/24/2022
Device Model NumberM00567340
Device Catalogue Number6734
Device Lot Number0025634739
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/06/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/24/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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