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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL BRK-1 XS TRANSSEPTAL NEEDLE, 71 CM LENGTH; TROCAR

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ST. JUDE MEDICAL BRK-1 XS TRANSSEPTAL NEEDLE, 71 CM LENGTH; TROCAR Back to Search Results
Model Number G407209
Device Problems Difficult to Insert (1316); Component Misassembled (4004)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/10/2020
Event Type  Injury  
Manufacturer Narrative
The results, method and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
Related manufacturing ref: 3008452825-2020-00638, 3008452825-2020-00642.During the procedure, a clinically significant delay occurred to puncture difficulties.During transseptal puncture, difficulty was noted puncturing the septum while using an sl0 sheath with a brk xs transseptal needle.A brk-1 xs needle was then obtained and when attempting to puncture the septum, the puncture remained difficult.A third transseptal needle was tried with a brk xs needle which had the same problem.A brk-1 needle was then used with a swartz introducer to perform transseptal puncture successfully.The procedure was completed with no adverse patient consequences.A clinically significant delay occurred due to these issues.When comparing the brk¿ xs transseptal needle, 71 cm to the brk-1¿ xs, there was no difference in the curves.
 
Manufacturer Narrative
The device was not returned.However, the event was confirmed to be manufacturing related.An incorrect brk-1 needle, xs sharp packaging issue has been confirmed for lot 7620873.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with abbott specifications and procedures.Based on the investigation performed and the information provided the cause of the even was determined to be manufacturing related.As a result of this finding, abbott is performing further investigation.
 
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Brand Name
BRK-1 XS TRANSSEPTAL NEEDLE, 71 CM LENGTH
Type of Device
TROCAR
Manufacturer (Section D)
ST. JUDE MEDICAL
parque industrial, zona franca coyol s.a.
edificio #44b, calle 0, avenida 2, coyol
alajuela, costa rica 1897- 4050
CS  1897-4050
MDR Report Key10864634
MDR Text Key217093561
Report Number3008452825-2020-00639
Device Sequence Number1
Product Code DRC
UDI-Device Identifier05414734205184
UDI-Public05414734205184
Combination Product (y/n)N
PMA/PMN Number
K122587
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/31/2023
Device Model NumberG407209
Device Catalogue NumberG407209
Device Lot Number7620873
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/10/2020
Initial Date FDA Received11/18/2020
Supplement Dates Manufacturer Received01/25/2021
Supplement Dates FDA Received01/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
BRK XS; BRK XS
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