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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER TORQVUE LP CATHETER CATHETER, PERCUTANEOUS

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ABBOTT MEDICAL AMPLATZER TORQVUE LP CATHETER CATHETER, PERCUTANEOUS Back to Search Results
Model Number 9-TVLPC4F90/080
Device Problem Biocompatibility (2886)
Patient Problems Arrhythmia (1721); Pericardial Effusion (3271); Heart Block (4444)
Event Date 03/05/2021
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 reference number: (b)(4). On (b)(6), 2021, a 4/2 amplatzer piccolo occluder was selected for implant in a 22 day old, 780g patient with the following patent ductus arteriosus(pda) dimensions: minimal diameter of 2. 4mm, diameter at aortic ampulla of 3. 4mm and pda length of 6mm. Using an amplatzer torqvue lp catheter the device was placed intraductal and it was noticed via echo and fluoroscopy that the device was oversized. The physician recaptured the device prior to release from the delivery cable and removed it from the patient. A 3/2mm amplatzer piccolo occluder was then selected for implant. The 3/2mm device was implanted intraductal and appeared to be the correct size for closure, as it appeared to sit well. After careful consideration the physician was satisfied with the device placement and released the 3/2mm amplatzer piccolo occluder in the pda. The physician then proceeded to perform a final angiogram to confirm placement after release. Angiogram showed a pericardial effusion in the patient. The patient then went into complete heart block. The patient was treated with atropine and epinephrine. The patient was then carefully observed and noted to go into second degree heart block and after more observation the patient went into bigeminy. After some time the patient reverted back into sinuous rhythm. A final angiogram was repeated and confirmed correct placement of the device and only a trivial effusion was remaining on fluoroscopy. There was a reported clinically significant delay in the procedure. The 3/2mm device remains implanted and the patient will be carefully monitored and a follow up echo will be performed. The patient is currently stable. The physician believes the injury may have occurred due to the delivery cable or catheter.

 
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Brand NameAMPLATZER TORQVUE LP CATHETER
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
ABBOTT MEDICAL
5050 nathan lane north
plymouth MN 55442
Manufacturer (Section G)
ABBOTT MEDICAL
5050 nathan lane north
plymouth MN 55442
Manufacturer Contact
pamela yip
5050 nathan lane n
plymouth, MN 55442
6517565400
MDR Report Key11607829
MDR Text Key249447244
Report Number2135147-2021-00120
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK162228
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/28/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/02/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number9-TVLPC4F90/080
Device Catalogue Number9-TVLPC4F90/080
Device LOT Number7565005
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/20/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/24/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/02/2021 Patient Sequence Number: 1
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