FDA Adverse Event Malfunction Summary report: N

VAXCEL PICC

MDR report key: 731209 · Received June 23, 2006

Report

Report Number: 6000126-2006-00093
Event Type: Malfunction
Date Received: June 23, 2006
Report Date: May 30, 2006
Manufacturer: BOSTON SCIENTIFIC
Product Code: LJS
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

H4-USER FACILITY WAS UNABLE TO SUPPLY THE CORRECT LOT NUMBER OF THE DEVICE USED; CONSEQUENTLY, THE MANUFACTURE DATE OF THE DEVICE IS UNK. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS THE DEVICE WAS DISPOSED; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND WE ARE NOT ABLE TO DETERMINE IF THE DEVICE MET SPECIFICATION. SHOULD FURTHER RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED UNDER THE APPROPRIATE SEQUENCE NUMBER. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE FOR THIS EVENT. OUR DIRECTIONS FOR USE OUTLINE APPROPRIATE PLACEMENT, ACCESS AND MAINTENANCE PROCEDURES. BSC REFERENCE # A00024677-(TW 131966). DATE FILED: 23 JUNE 2006.

Description of Event or Problem · 1

THE COMPLAINANT REPORTED THAT A VAXCEL PICC WAS THERAPEUTICALLY PLACED IN THE BASILICA VEIN OF A PATIENT (AGE AND GENDER UNKNOWN). THE DATE OF IMPLANTATION OF THE DEVICE WAS UNABLE TO BE OBTAINED. DURING FLUSHING OF THE DEVICE, SOMETIME SUBSEQUENT TO THE IMPLANT, THE CATHETER WAS OBSERVED TO BE LEAKING IN A LOCATION DISTAL TO THE SUTURE WING. A REPLACEMENT DEVICE WAS SUCCESSFULLY IMPLANTED IN THE PATIENT, AND THE COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE AFFECT ON THE PATIENT AS A RESULT OF THE REPORTED PROBLEM.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	VAXCEL PICC	VENOUS ACCESS SYSTEM	LJS	BOSTON SCIENTIFIC	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNKNOWN