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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 H7493918915250
Device Problem Bent (1059)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/07/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Device evaluated by mfr. : returned product consisted of an apex balloon catheter. The balloon was loosely folded with blood in the hub and lumen. The tip of the device was not returned for analysis. There were numerous kinks in the hypotube. Analysis could not be done as the tip of the device was not returned with the complaint device. Microscopic inspection revealed only 6mm of the balloon was returned, and a full circumferential tear/separation in the balloon material. Additional microscopic inspection of the device revealed a separation of the inner shaft located at the distal end of the port/exit notch, with additional damage (stretched) dome to the notch. There were numerous kinks in the hypotube. 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 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 27-may-2016. It was reported that tip damage occurred. The target lesion was located in the right coronary artery. A 3. 00mmx30mm apex¿ balloon catheter was selected for dilation; however upon insertion, the tip of balloon got damaged. The procedure was completed with a different device. No patient complications were reported and the patient's status was fine. However, returned device analysis revealed balloon and tip detachment.
 
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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 Key5739555
MDR Text Key47895696
Report Number2134265-2016-05312
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113220
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 05/27/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/21/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2018
Device Model NumberH7493918915250
Device Catalogue Number39189-1525
Device Lot Number0018074022
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/14/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/27/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/09/2015
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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