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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC LAUNCHER 6F GUIDE CATHETER CATHETER, PERCUTANEOUS

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MEDTRONIC, INC LAUNCHER 6F GUIDE CATHETER CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number LA6AL10
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/07/2018
Event Type  malfunction  
Manufacturer Narrative
Product analysis summary: the balloon catheters used in the case were not returned for analysis with the launchers. As received the catheter appears undamaged. The catheter was flushed with water into a strainer. No debris came out. An. 035¿ wire passed through the lumen without resistance. The inner diameter meets specification at. 071¿. The presence of purple staining after dye tests confirms the presence of lumen lubricant. Dissection revealed coagulated blood and debris measuring less than 1 mm in size in the catheter lumen mid shaft and distal end of the catheter. The debris was sent for testing. Ftir results show the unknown materials are composed of polyurethane. The guide catheter is composed of pebax and vestamide (inner and outer jacket of catheter, respectively) and are chemically different. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Two launcher guide catheters, one la6al10 and one la6sal10; were intended to be used to treat moderately tortuous, moderately calcified in the rca and lad, cass # 2 and 12. There was no damage noted to the device packaging. The devices were removed from the packaging with no issues. The devices were inspected with no issues. The devices were prepped per ifu with no issues. No issues were noted during maneuvering and engaging the launchers to the lesion. Resistance was encountered when advancing the balloon catheters and stents (all non-medtronic) in the launchers at straight section proximal to the secondary curve. Excessive force was not used during delivery. No patient injury is reported. The procedure was completed by replacing the launchers with non-medtronic devices. The physician felt as if the device tip hit something inside the launcher, and resistance persisted afterwards.
 
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Brand NameLAUNCHER 6F GUIDE CATHETER
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC, INC
37a cherry hill dr
danvers MA 01923
Manufacturer (Section G)
MEDTRONIC, INC
37a cherry hill dr
danvers MA 01923
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key8390196
MDR Text Key137838305
Report Number1220452-2019-00020
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K132673
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 03/05/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/09/2020
Device Catalogue NumberLA6AL10
Device Lot Number0008942982
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/21/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/25/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/09/2018
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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