MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-06-16 for VAXCEL WITH PASV PICC 4FR SL * manufactured by Boston Scientific Corp.
[327014]
This is the 2nd breakage of this catheter on this pt. Fortunately, all therapy is completed. Did not need to insert another iv line.
Patient Sequence No: 1, Text Type: D, B5
[20933564]
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
| Report Number | MW1028740 |
| MDR Report Key | 467089 |
| Date Received | 2003-06-16 |
| Date of Report | 2003-06-16 |
| Date of Event | 2003-05-20 |
| Date Added to Maude | 2003-06-24 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VAXCEL WITH PASV PICC 4FR SL |
| Generic Name | VASCULAR ACCESS DEVICE |
| Product Code | FKO |
| Date Received | 2003-06-16 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 4010203229 |
| ID Number | * |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 456034 |
| Manufacturer | BOSTON SCIENTIFIC CORP |
| Manufacturer Address | 3598 WEST 1820 SOUTH SALT LAKE CITY UT 84104 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-06-16 |