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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE DIREXION HI-FLO; CATHETER, CONTINUOUS FLUSH
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BOSTON SCIENTIFIC - MAPLE GROVE DIREXION HI-FLO; CATHETER, CONTINUOUS FLUSH Back to Search Results
Model Number UNK783
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/16/2018
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older.(b)(4).
 
Event Description
It was reported that the catheter tip was punctured.The target area was located in the mildly tortuous and mildly calcified gastrointestinal (gi) tract.A direxion hi-flo was selected for use.During a gi bleed embolization procedure, it was noted that the direxion microcatheter was sticking when entering the non bsc guide catheter.Furthermore, when the direxion was taken out, the catheter became stretched and the lumen lost its integrity.After retrieval, a puncture was noted on the tip of the direxion catheter.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was okay.
 
Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.Returned product consisted of a direxion micro-catheter with an.016 guidewire returned in the device.A cordis 5fr guide catheter was also returned.The shaft was examined.The device showed damage in the form of a broken shaft in 2 locations.The 1st location was 132cm from the hub and the 2nd was located 133cm from the hub.The outer diameter (od) of the direxion catheter was measured on the led micrometer.The maximum od that was measured was.0387.The customer stated they were using a 5fr cordis catheter which has an id of.040.The direxion device that the customer chose is compatible with a 5fr cordis catheter.The guidewire was hydrated as well as the returned cordis catheter.The guidewire was inserted into the direxion and then it was attempted to be inserted into the cordis catheter.The damage on the micro-catheter would buckle and bunch up upon insertion; therefore, it would not transcend through the cordis device.The perforation/hole that was said to be noticed on the device was not confirmed.Inspection of the remainder of the device, revealed no other damage or irregularities.No other issues were identified during the product analysis.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).
 
Event Description
It was reported that the catheter tip was punctured.The target area was located in the mildly tortuous and mildly calcified gastrointestinal (gi) tract.A direxion hi-flo was selected for use.During a gi bleed embolization procedure, it was noted that the direxion microcatheter was sticking when entering the non bsc guide catheter.Furthermore, when the direxion was taken out, the catheter became stretched and the lumen lost its integrity.After retrieval, a puncture was noted on the tip of the direxion catheter.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was okay.
 
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Brand Name
DIREXION HI-FLO
Type of Device
CATHETER, CONTINUOUS FLUSH
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 Key7767912
MDR Text Key116601605
Report Number2134265-2018-07104
Device Sequence Number1
Product Code KRA
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
K132947
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberUNK783
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/25/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/13/2018
Was Device Evaluated by Manufacturer? Yes
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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