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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE EMERGE¿; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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BOSTON SCIENTIFIC - MAPLE GROVE EMERGE¿; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number H7493919320300
Device Problems Break (1069); Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 02/22/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).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 med watch will be filed.(b)(4).
 
Event Description
It was reported that shaft break occurred.During preparation of a 3.00mm x 20mm emerge¿ balloon catheter, the balloon was folded out of the package and during manipulation, the catheter body fractured.The device never entered the patient's body and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
 
Manufacturer Narrative
Device avail.For eval, returned to mfr.On, device returned to mfr., device evaluated by mfr.Device evaluated by mfr.: returned product consisted of the emerge balloon catheter in two pieces.The hypotube and shaft were microscopically examined.There was contrast in the inflation lumen and blood in the guidewire lumen.Although it was reported that the device was not used in the body, the presence of blood in the guidewire lumen is indicative of handling beyond simply unpackaging or prepping the device.There were numerous kinks throughout the hypotube of the device.There was a complete hypotube separation 56cm from the strain relief.The hypotube fracture surface was ovaled, which suggests the device was kinked prior to separation.The tip was damaged.Inspection of the remainder of the device revealed no other damage or irregularities.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 operational context as device performance was limited due to anatomical/procedural factors.(b)(4).
 
Event Description
It was reported that shaft break occurred.During preparation of a 3.00mm x 20mm emerge¿ balloon catheter, the balloon was folded out of the package and during manipulation, the catheter body fractured.The device never entered the patient's body and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
 
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Brand Name
EMERGE¿
Type of Device
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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 Key6487593
MDR Text Key72657499
Report Number2134265-2017-03725
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K113220
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 03/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2019
Device Model NumberH7493919320300
Device Catalogue Number39193-2030
Device Lot Number20070536
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/11/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/12/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/13/2016
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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