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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE MAVERICK²¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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BOSTON SCIENTIFIC - MAPLE GROVE MAVERICK²¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number H7493892812350
Device Problems Bent (1059); Failure to Advance (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/07/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Device evaluated by mfr. : returned product consisted of a maverick 2 balloon catheter in two pieces. The balloon was loosely folded. The outer shaft, inner shaft, balloon and tip were microscopically examined. The hypotube was completely separated 85. 1cm from the hub. The fracture faces were oval as if kinked prior to separation. There is shaft damage at the exit notch that is consistent with damage seen with the use of a guidewire. The tip is damaged. There are numerous hypotube and shaft kinks. Inspection of the remainder of the device presented no other damage or irregularities. There was no evidence of any material or manufacturing deficiencies contributing to the damage and the reported difficulty. The investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited. (b)(4).
 
Event Description
Reportable based on device analysis completed on (b)(6) 2017. It was reported that crossing difficulties were encountered and shaft damage occurred. The 82% stenosed target lesion was located in the moderately tortuous and severely calcified mid right coronary artery. Following pre-dilation with a 3. 0x12mm non-bsc balloon catheter, a 3. 50mmx12mm maverick balloon catheter was advanced for dilation. However, the device failed to cross the lesion and the mid shaft was damaged. The procedure was completed with a different device. No patient complications were reported and the patient's status was stable. However, returned device analysis revealed hypotube break.
 
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Brand NameMAVERICK²¿
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 Key7159280
MDR Text Key96234296
Report Number2134265-2017-12776
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeKR
PMA/PMN Number
P860019
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 12/12/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/24/2020
Device Model NumberH7493892812350
Device Catalogue Number38928-1235
Device Lot Number20927687
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/24/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/12/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/29/2017
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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