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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PWP CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC
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PWP CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Model Number 150075
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Arrhythmia (1721)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
A pwp catheter was attempted to be used during a rhc procedure for implant of a non-medtronic device.It was reported that movement of the pwp device caused a heart block.The patient received atropine and the issue resolved without any further intervention.The procedure was successfully completed with no adverse patient consequences.
 
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Brand Name
PWP CATHETER
Common Device Name
CATHETER, INTRAVASCULAR, DIAGNOSTIC
MDR Report Key10605550
Report Number1220452-2020-00078
Device Sequence Number16879048
Product Code DQO
UDI-Device Identifier00613994733658
UDI-Public00613994733658
Combination Product (Y/N)N
Initial Reporter StateLA
Initial Reporter CountryUS
PMA/510(K) Number
K884065
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date01/06/2022
Device Model Number150075
Device Catalogue Number150075
Device Lot Number0010082305
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/03/2020
Initial Report FDA Received Date09/30/2020
Date Device Manufactured01/07/2020
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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