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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 H7493892820250
Device Problem Kinked (1339)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/14/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Age at time of event: 18 years or older. Device evaluated by mfr: returned product consisted of a maverick 2 balloon catheter in two pieces. The balloon was tightly folded and there was blood in the lumen. The hypotube and inner/outer shaft was microscopically examined. Inspection revealed a kink in the hypotube 86cm from the strain relief with a separation in the hypotube 88cm from the strain relief. The fracture faces were oval as if kinked prior to separation. There was no evidence of any material or manufacturing deficiencies contributing to the damage. 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 15-sep-2016. It was reported that shaft kink occurred. The 85% stenosed, 28mm in length target lesion was located in the moderately tortuous, moderately calcified, and 3. 00mm in diameter left anterior descending artery. A 2. 50mm x 20mm maverick²¿ balloon catheter was advanced to treat the lesion. However, the shaft was noted to be kinked. The procedure was completed with another of the same device. No patient complications were reported and the patient's status was stable. However, returned device analysis revealed hypotube break. It was further reported that during advancing of the device, the shaft broke.
 
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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
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key6021997
MDR Text Key57184812
Report Number2134265-2016-08900
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCN
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 09/15/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/12/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2019
Device Model NumberH7493892820250
Device Catalogue Number38928-2025
Device Lot Number18792558
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/31/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/15/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/12/2016
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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