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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - MAPLE GROVE QUANTUM¿ MAVERICK¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number H7493808012350
Device Problem Kinked (1339)
Patient Problem No Patient Involvement (2645)
Event Date 02/27/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Device evaluated by mfr. : returned product consisted of a quantum maverick balloon catheter in two pieces. The shaft and hypotube were microscopically and visually examined. There was contrast in the inflation lumen and blood in the guidewire lumen. Although it was reported that the device was not used, the presence of blood in the guidewire lumen and contrast media in the inflation lumen is indicative of handling beyond simply unpackaging the device, as was reported. The balloon was tightly folded. There was a complete hypotube separation 73 cm from the strain relief and numerous hypotube kinks. The hypotube fracture surfaces were ovaled, which suggests the device was kinked prior to separation. Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities. No other issues were identified during the product analysis. 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 analysis completed on 26may2017. It was reported that shaft kink occurred. A 3. 5mm x 12mm quantum¿ maverick¿ balloon catheter was selected for use. During unpacking, it was noted that the delivery shaft was kinked. The device never went inside the patient's body and 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 a hypotube break.
 
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Brand NameQUANTUM¿ MAVERICK¿
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 Key6613167
MDR Text Key76735915
Report Number2134265-2017-05881
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 05/26/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/05/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2019
Device Model NumberH7493808012350
Device Catalogue Number38080-1235
Device Lot Number19586826
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/16/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/26/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/15/2016
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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