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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE FETCH®2; CATHETER, EMBOLECTOMY
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BOSTON SCIENTIFIC - MAPLE GROVE FETCH®2; CATHETER, EMBOLECTOMY Back to Search Results
Model Number 109400-001
Device Problem Crack (1135)
Patient Problem No Patient Involvement (2645)
Event Date 08/20/2015
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
 
Event Description
It was reported that the shaft was cracked.Prior to using a fetch2 thrombectomy catheter it was noted that the device was cracked.The device did not enter the patient and no patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a fetch 2 aspiration device.The syringe and extension line that is shipped with the device was not returned by the customer.Visual inspection of the device revealed a kink approximately 17cm from the strain relief.Visual and tactile analysis noted one kink on the catheter shaft.Inside diameter of proximal of the shaft was inspected using a.045 gauge pin and the result was that proximal shaft was in specification.The catheter was not functionally tested due to the damage on the catheter shaft.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).
 
Event Description
It was reported that the shaft was cracked.Prior to using a fetch2 thrombectomy catheter it was noted that the device was cracked.The device did not enter the patient and no patient complications were reported.
 
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Brand Name
FETCH®2
Type of Device
CATHETER, EMBOLECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
Manufacturer Contact
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key5093757
MDR Text Key26430545
Report Number2134265-2015-06312
Device Sequence Number1
Product Code DXE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101354
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other
Type of Report Followup
Report Date 08/26/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/11/2017
Device Model Number109400-001
Device Lot Number0000186151
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/25/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/22/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received11/18/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/12/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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