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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE IMPULSE GUIDE CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC
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BOSTON SCIENTIFIC - MAPLE GROVE IMPULSE GUIDE CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Model Number H74916391402
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Patient Involvement (2645)
Event Date 11/10/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a foreign material was found inside the package.During inspection, it was noted that a human hair was found inside the sterile package of an impulse guide catheter.No patient involvement reported.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a foreign material was found inside the package.During inspection, it was noted that a human hair was found inside the sterile package of an impulse guide catheter.No patient involvement reported.
 
Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.Visual inspection of the pouch and it¿s contents revealed foreign matter(hair) approximately 9cm in length, exceeding product specification, inside of the sealed barrier and the outside of the packaging revealed foreign matter, exceeding product specification.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause has been determined to be related to a supplier manufacturing issue.(b)(4).
 
Event Description
It was reported that a foreign material was found inside the package.During inspection, it was noted that a human hair was found inside the sterile package of an impulse guide catheter.No patient involvement reported.
 
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Brand Name
IMPULSE GUIDE CATHETER
Type of Device
CATHETER, INTRAVASCULAR, DIAGNOSTIC
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
Manufacturer (Section G)
AVAIL MEDICAL PRODUCTS INCORPORATED
5950 nancy ridge drive
san diego CA 92121
Manufacturer Contact
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key5264546
MDR Text Key32618408
Report Number2134265-2015-08319
Device Sequence Number1
Product Code DQO
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K992142
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Health Professional
Type of Report Initial,Followup,Followup
Report Date 11/10/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/28/2017
Device Model NumberH74916391402
Device Catalogue Number16391-40
Device Lot Number0050871708
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/28/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/09/2015
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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