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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 Problems Bent (1059); Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 04/21/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(6). (b)(4). Device evaluated by mfr. : returned product consisted of a quantum maverick balloon catheter. The balloon was loosely folded and there was contrast in the lumen. Microscopic and tactile inspection revealed a separation in the hypotube at 69. 5cm from the strain relief, with the fracture faces ovaled, as if kinked prior to separation. There were numerous kinks in the hypotube. Microscopic inspection found no irregularities or defects with the markerbands. Microscopic inspection found no irregularities or defects with the distal tip. Microscopic inspection found no irregularities or defects with the proximal bond. Functional testing was completed by attaching an inflation device filled with water to a toughy, and then tightening the toughy to the broken, distal end of the balloon catheter. When pressure was applied, the balloon inflated normally. Microscopic and visual inspection found no irregularities or defect with the balloon. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty. (b)(4).
 
Event Description
Reportable based on device analysis completed on 24-jun-2016. It was reported that balloon damage occurred. During preparation of a 3. 5mm x 12mm quantum¿ maverick¿ balloon catheter, the balloon was noted to have an unusual shape. The device never entered the patient's body and the procedure was completed with a different device. No patient complications were reported. 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
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key5808012
MDR Text Key49947292
Report Number2134265-2016-06280
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
PMA/PMN Number
P860019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 06/24/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/20/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2019
Device Model NumberH7493808012350
Device Catalogue Number38080-1235
Device Lot Number0019013735
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/20/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/24/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/09/2016
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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