MAUDE Adverse Event Report: ATC TECHNOLOGIES, INC. SPARROWHAWK; DEVICE, BIOPSY, ENDOMYOCARDIAL

Lot Number 041813

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 07/16/2018

Event Type  malfunction  

Event Description

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.

• Brand Name: SPARROWHAWK
• Type of Device: DEVICE, BIOPSY, ENDOMYOCARDIAL
• Manufacturer (Section D): ATC TECHNOLOGIES, INC.; 30-b upton drive; wilmington MA 01887
• MDR Report Key: 7693471
• MDR Text Key: 114159656
• Report Number: 7693471
• Device Sequence Number: 1
• Product Code: DWZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 041813
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/16/2018
• Event Location: Hospital
• Date Report to Manufacturer: 07/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 2920 DA
• Patient Weight: 23