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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMERGE CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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BOSTON SCIENTIFIC CORPORATION EMERGE CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 7134
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/02/2020
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by mfr. : the returned complaint device consisted of an emerge balloon catheter. The balloon was loosely folded. The hypotube, outer shaft, inner shaft, balloon and tip were visually and microscopically examined. The hypotube was completely separated 72cm from the hub. The hypotube fracture surfaces were ovaled and torn, which suggests the device was kinked prior to separation. There were numerous hypotube and shaft kinks along the device. Inspection of the remainder of the device presented no other damage or irregularities. Product analysis found damage that could have contributed to the reported event.
 
Event Description
Reportable based on device analysis completed on 26-jul-2020. It was reported that shaft kink occurred. The 85% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery. A 2. 00mm x 20mm emerge balloon catheter was advanced for dilatation. However, it was noted that the delivery shaft was kinked. The procedure was completed with another of same device. No patient complications were reported and the patient's status was stable. However, returned device analysis revealed shaft detached/separated.
 
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Brand NameEMERGE
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key10421208
MDR Text Key203355657
Report Number2134265-2020-11286
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCH
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 08/18/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/17/2022
Device Model Number7134
Device Catalogue Number7134
Device Lot Number0024300699
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/25/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/26/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/21/2019
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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