FDA Adverse Event Malfunction Summary report: N

EXTRACTOR RX RETRIEVAL BALLOON

MDR report key: 1102105 · Received August 7, 2008

Report

Report Number: 3005099803-2008-01453
Event Type: Malfunction
Date Received: August 7, 2008
Date of Event: July 9, 2008
Report Date: July 9, 2008
Manufacturer: BOSTON SCIENTIFIC
Product Code: FGE
PMA / PMN Number: K970052
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE ANALYSIS: THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem · 1

SAME CASE AS MFT REPORT #3005099803-2008-01455. IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE THE BALLOON FAILED TO INFLATE. THE TARGET LESION WAS IN THE COMMON BILE DUCT (CBD). THE PHYSICIAN ADVANCED A 12-15MM ABOVE EXTRACTOR RX RETRIEVAL BALLOON TO THE TARGET LESION BUT THE DEVICE WOULD NOT INFLATE. THE PHYSICIAN ADVANCED ANOTHER 12-15MM ABOVE EXTRACTOR RX RETRIEVAL BALLOON TO THE TARGET LESION, BUT THIS DEVICE ALSO FAILED TO INFLATE. BOTH DEVICES WERE TESTED OUTSIDE THE BODY WHERE THEY WERE FOUND TO BE 'BROKEN". THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR RX RETRIEVAL BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED WITH THE PATIENT'S CURRENT CONDITION LISTED AS "FINE".

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	EXTRACTOR RX RETRIEVAL BALLOON		FGE	BOSTON SCIENTIFIC	M00546910	11516292

Patients

Seq	Age	Sex	Outcome	Treatment
1