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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COYOTE; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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BOSTON SCIENTIFIC CORPORATION COYOTE; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 24706
Device Problem Material Rupture (1546)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2024
Event Type  malfunction  
Manufacturer Narrative
B3 - date of event: used 03/01/2024 as the event date was not reported.
 
Event Description
It was reported that balloon rupture occurred.A 2.0mm x 220mm x 150cm coyote balloon was advanced for dilation.However, it was noted that the balloon ruptured before reaching the rated burst pressure.No patient complications were reported.
 
Manufacturer Narrative
B3 date of event: used 03/01/2024 as the event date was not reported.Device evaluated by mfr: the complaint device was received for product analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a pinhole 7mm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there is a pinhole in the balloon.
 
Event Description
It was reported that balloon rupture occurred.A 2.0mm x 220mm x 150cm coyote balloon was advanced for dilation.However, it was noted that the balloon ruptured before reaching the rated burst pressure.No patient complications were reported.
 
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Brand Name
COYOTE
Type of Device
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key19094791
MDR Text Key339998668
Report Number2124215-2024-21800
Device Sequence Number1
Product Code DQY
UDI-Device Identifier08714729796466
UDI-Public08714729796466
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111295
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/24/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number24706
Device Catalogue Number24706
Device Lot Number0031163717
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/08/2024
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/17/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/03/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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