VAXCEL WITH PASV PICC(PERIPHERALLY INSERTED CENTRAL CATHETER *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-06-17 for VAXCEL WITH PASV PICC(PERIPHERALLY INSERTED CENTRAL CATHETER * manufactured by Boston Scientific Corporation.

Event Text Entries

[342360] Add'l info rec'd from mfr 10/10/03: all of the reported experiences describe a break in the extension tube (or a hole) that developed during use. There were no pt injuries. None of the incidents were reported to bsc by the customer. Mfr entered the incidents into its complaint system and initiated follow-up to obtain a detailed description. Rptr stated that all of the sample products involved had been discarded. They had no add'l info about the incidents, except that the tubing fractured at the junction of the extension part of the catheter and the hub. No sample was returned for methodologies to be applied. No sample was returned for identification/confirmation of the failure mode(s). No conclusions could be made, since no samples were returned. Although boston scientific corp did not receive a product sample from the facility for these specific medwatch reports, it has complaints on file for similar experiences with this device. Co's investigations into these complaints had already indicated that inappropriate use of alcohol or acetone can result in this type of failure. Co instituted inservice training among customers, including this customer to reinforce the proper handling and care per the dfu. The dfu contains a precaution stating "care should be taken when using alcohol or acetone. Allow for complete drying of alcohol or acetone during routine care and maintenance". None of the devices involved in these incidents were returned to boston scientific. The device was destroyed/discarded by the customer. Although there was no customer complaint submitted or product returned for these medwatch reports, this customer had returned product previously and the info gained from evaluation of that product was used in this response. During co's investigations, it confirmed the catheter extension tube's susceptibility to kinking and flexing in combination with alcohol contact. In addition, co discovered that the extension tube's resistance to kinking and alcohol could be made more robust with a minor processing change. The extension tubes are then processed through the original catheter assembly process. This change was approved and implemented in june 2003.
Patient Sequence No: 1, Text Type: D, B5


[19950737] Picc line broke at the junction of the hub and external part of catheter. As the md was removing picc line in 2003, he had difficulty and broke catheter. Because of this, pt missed 3 doses of vancomycin iv and had to stay an extra day at the hospital.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1028754
MDR Report Key467322
Date Received2003-06-17
Date of Report2003-06-05
Date of Event2003-05-31
Date Added to Maude2003-06-25
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameVAXCEL WITH PASV PICC(PERIPHERALLY INSERTED CENTRAL CATHETER
Generic NameVASCULAR ACCESS DEVICE
Product CodeFKO
Date Received2003-06-17
Returned To Mfg2003-06-02
Model Number*
Catalog Number*
Lot Number4010403115
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key456267
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer Address3598 WEST 1820 SOUTH SALT LAKE CITY UT 84104 US


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Other 2003-06-17

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