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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MEXICO NC SPRINTER RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY,

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MEDTRONIC MEXICO NC SPRINTER RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, Back to Search Results
Catalog Number NCSP3015X
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/11/2021
Event Type  malfunction  
Manufacturer Narrative
Device returned for evaluation. Kinks were noted on the hypotube. There was a detachment on the hypotube 24. 2cm distal to the strain relief. The hypotube material was oval and jagged on both sides of the detachment site. The balloon folds were intact. No inflation had been performed. No damage was noted to the distal tip. No other damage evident to the remainder of the device. If information is provided in the future, a supplemental report will be issued.
 
Event Description
During a procedure an attempt was made to use one nc sprinter rx ptca balloon catheter to treat a moderately tortuous, moderately calcified lesion exhibiting 80% stenosis located in the ostium of the right coronary artery (rca) and the right posterior descending (r-pda) artery. The device was inspected with no issues noted. Negative prep was performed with no issues noted. The lesion was not pre-dilated. The device did pass through a previously deployed stent. Resistance was not encountered when advancing the device. Excessive force was not used during delivery. It was reported that the balloon failed to cross through patent struts in the pda to perform kissing at bifurcation technique. The patient was reported to be alive with no injuries.
 
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Brand NameNC SPRINTER RX
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY,
Manufacturer (Section D)
MEDTRONIC MEXICO
av. paseo del cucapah #10510
tijuana,bc 22570
MX 22570
Manufacturer (Section G)
MEDTRONIC MEXICO
av. paseo del cucapah #10510
tijuana,bc 22570
MX 22570
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
EI  
091708734
MDR Report Key12031188
MDR Text Key257160777
Report Number9612164-2021-02392
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeEG
PMA/PMN Number
P790017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/20/2021
Device Catalogue NumberNCSP3015X
Device Lot Number218328433
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/03/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/07/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/21/2019
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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