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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 H7493919312250
Device Problems Detachment Of Device Component (1104); Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by mfr. : returned product consisted of an emerge balloon catheter with no other devices. The balloon was tightly folded. The balloon protector was over the balloon and the product mandrel was in the lumen. The distal tip was not damaged and was still attached to the catheter. The hypotube was completely separated at the strain relief. The fracture faces were oval as if kinked prior to separation. There were numerous hypotube kinks. 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 tip detachment occurred. During unpacking of a 2. 50mm x 12mm emerge¿ balloon catheter, it was noted that the proximal tip of the device was twisted on its proximal section and upon removal from the sheath, the tip detached from the rest of the catheter. The sheath and the packaging were intact. No patient complications were reported.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that tip detachment occurred. During unpacking of a 2. 50mm x 12mm emerge¿ balloon catheter, it was noted that the proximal tip of the device was twisted on its proximal section and upon removal from the sheath, the tip detached from the rest of the catheter. The sheath and the packaging were intact. No patient complications were reported.
 
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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
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key7117012
MDR Text Key263087697
Report Number2134265-2017-12323
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K113220
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 11/28/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/14/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/08/2020
Device Model NumberH7493919312250
Device Catalogue Number39193-1225
Device Lot Number21120231
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/11/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/25/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/18/2017
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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