SPARROWHAWK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-17 for SPARROWHAWK manufactured by Atc Technologies, Inc..

Event Text Entries

[114159656] Patient presented for post heart transplant routine myocardial biopsies. Two endomyocardial biopsy specimens were removed with a sparrowhawk 5 fr 50 cm bioptome. On the third attempt a snap was reported to have been felt. The wire broke and jaws of the bioptome remained in the open position. The bioptome could not be pulled into the 5 fr long sheath and attempts to close the bioptome jaws using the actuator, wire and outside spring was unsuccessful. A tee confirmed that the open bioptome jaws were located at the anterior leaflet of the tricuspid valve or in the chordae right below the valve. Attempts to manipulate the bioptome in a rotational fashion did not change the position of the tip of the bioptome. With the bioptome in the valve there was moderate tricuspid regurg. Access was obtained over the 5 fr sheath. A 7 fr sheath was place and the bioptome was able to be pulled into the sheath and removed. Heparin was given during this process. There was clot along the bioptome after it was removed. Following removal of the bioptome a tee was performed. The tricuspid valve was reported to have good function with mild regur (unchanged from prior exams pre biopsy) there was no evidence of flail tricuspid valve. The right and left ventricular function was normal. No clot seen in the ra or rv. Manufacturer response for biopsy forcepts, sparrowhawk (per site reporter). Representative for the manufacturer was reported to by contact. I do not have access to the response at this writing.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number7693471
MDR Report Key7693471
Date Received2018-07-17
Date of Report2018-07-16
Date of Event2018-07-16
Report Date2018-07-16
Date Reported to FDA2018-07-16
Date Reported to Mfgr2018-07-17
Date Added to Maude2018-07-17
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSPARROWHAWK
Generic NameDEVICE, BIOPSY, ENDOMYOCARDIAL
Product CodeDWZ
Date Received2018-07-17
Lot Number041813
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerATC TECHNOLOGIES, INC.
Manufacturer Address30-B UPTON DRIVE WILMINGTON MA 01887 US 01887


Patients

Patient NumberTreatmentOutcomeDate
10 2018-07-17

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