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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE COYOTE¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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BOSTON SCIENTIFIC - MAPLE GROVE COYOTE¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number H74939186302210
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Patient Involvement (2645)
Event Date 03/09/2018
Event Type  malfunction  
Manufacturer Narrative
Returned product consisted of a coyote balloon catheter inside of a tyvek pouch. The pouch was visually inspected. Inspection revealed that the bottom of the tyvek pouch was missing the manufacture seal. Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities. The investigation conclusion is manufacturing execution error as the manufacturing process was not executed as validated/as designed. (b)(4).
 
Event Description
It was reported that the product's sterility was compromised. During unpacking of a 3. 0mm x 220mm x 150cm coyote balloon catheter, it was noted that the inner pouch was completely open at the back. The procedure was completed with another coyote balloon catheter. No patient complications were reported and the patient's status was good.
 
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Brand NameCOYOTE¿
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key7406942
MDR Text Key104807326
Report Number2134265-2018-02540
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K111295
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 03/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/21/2021
Device Model NumberH74939186302210
Device Catalogue Number39186-30221
Device Lot Number0021640140
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/20/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/12/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/22/2018
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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