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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 H7493919312220
Device Problem Fluid Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/23/2016
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an emerge balloon catheter. There was blood in the inflation lumen and balloon. The balloon was tightly folded. Microscopic examination presented no damage or irregularities with the bonds. Tactile inspection and microscopic examination revealed that the outer and inner shafts were torn 7mm distal of the exit notch. The damage is consistent with interaction with another device. There were numerous kinks throughout the shaft. Microscopic examination presented no irregularities in the shaft material that could have contributed to the damage. Tactile inspection and microscopic examination presented no damage or irregularities to the hypotube. Functional testing was performed by attaching an inflation device filled with water to the hub of the device. When positive pressure was applied, a stream of water emitted from the tear in the shaft wall. Inspection of the remainder of the device, apart from the observed damage, 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
Reportable based on device analysis completed on 15-mar-2016. It was reported that shaft leak occurred. The target lesion was located in a coronary artery. A 2. 25mm x 12mm emerge¿ balloon catheter was advanced for dilatation. However, during inflation, water was noted to be leaking from the hypotube. The procedure was completed with another of the same device. No patient complications were reported and the patient's status was good. However, returned device analysis revealed outer and inner shaft tear.
 
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Brand NameEMERGE¿
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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 Key5548204
MDR Text Key41904326
Report Number2134265-2016-02844
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
PMA/PMN Number
K113220
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 03/15/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/05/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2017
Device Model NumberH7493919312220
Device Catalogue Number39193-1222
Device Lot Number17438604
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/01/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/15/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/10/2014
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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