FDA Adverse Event Injury Summary report: N

ASAP BIOPSY DEVICE

MDR report key: 1525171 · Received November 9, 2009

Report

Report Number: 3005099803-2009-05276
Event Type: Injury
Date Received: November 9, 2009
Report Date: October 12, 2009
Manufacturer: BOSTON SCIENTIFIC CORPORATION
Product Code: FCG
PMA / PMN Number: K050120
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE MODEL NUMBER OR LOT NUMBER; THEREFORE, THE DEVICE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN.

Description of Event or Problem · 1

ON OCTOBER 12, 2009, A BOSTON SCIENTIFIC CORPORATION EMPLOYEE BECAME AWARE OF AN ARTICLE, "ACCURACY OF PERCUTANEOUS CORE BIOPSY IN MANAGEMENT OF SMALL RENAL MASSES" BY ROU WANG, ET. AL. PUBLISHED IN UROLOGY 73: 586-590, 2009. THE FOLLOWING INFORMATION WAS DERIVED FROM THIS ARTICLE: AN ASAP BIOPSY DEVICE WAS USED DURING A PERCUTANEOUS CORE BIOPSY OF THE RENAL MASS. ACCORDING TO THE ARTICLE, THE PATIENT DEVELOPED A POST-PROCEDURAL HEMATOMA IMMEDIATELY AFTER THE PROCEDURE. THE PATIENT WAS OBSERVED. ATTEMPTS HAVE BEEN UNSUCCESSFUL TO OBTAIN ADDITIONAL INFORMATION. THIS REPORT IS FOR ONE OF TWO DEVICES. REFER TO ASSOCIATED MANUFACTURE REPORT # 3005099803-2009-05275 FOR A DESCRIPTION OF THE SECOND DEVICE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ASAP BIOPSY DEVICE		FCG	BOSTON SCIENTIFIC CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other\| R