MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2006-08-30 for LR-PFTA-11.0 manufactured by Cook Vascular Inc..
[539163]
"pt died on ccl table following lead extraction procedure. Eds sheath would not track over pacing lead. Upon removal of sheath, a longitudinal dissection was observed at the distal tip of the sheath. The tip of the outer sheath was also observed to be deformed. It is possible initial damage occurred to the sheath earlier in the procedure when a locking stylet broke. " on 8/10/06 additional info received from cook, "consent was not given for an autopsy to be carried out and therefore, the exact cause of death remains undetermined; however, it is not believed to be associated with any equipment used during the lead extraction procedure. "
Patient Sequence No: 1, Text Type: D, B5
[7800965]
History: reported: "... Eds sheath would not track over pacing lead. Upon removal of sheath a longitudinal dissection was observed at the distal tip of the inner sheath. The tip of the outer sheath was also observed to be deformed. It is possible initial damage occurred to the sheath earlier in the procedure when a locking stylet broke... ". Analysis: the perfecta was returned along the outer sheath and the hooked stylet wire. The inner sheath was split approx 6cm along its length, on the distal end, opposite of the electrodes. Visual inspection revealed a buckling of the inner sheath located 4cm on the distal side of the handle. The distal tip of the outer sheath was also damaged. A series of small indentations lined the edges of the sheath. Buckling is also evident on the outer sheath approx 5cm from the distal tip. Impedance testing was performed on the device and it was found to be within manufacturing specifications. Conclusion: an uneven and lagged lacerated inner sheath could be created by a lead having its insulation compromised. The "zigzagging" nature of the laceration indicates that it was created incrementally with a directional change of the edge of device to be removed, in relation to the sheath. Indentations on the outer sheath appear to have been caused by the same type of device. A significant amount of force would be required to initiate a splitting of the inner sheath with a non-sharpened edge. The buckling of both sheaths and the lacerations appear to have been caused by forcing the sheaths against the pacemaker leads. An abnormal amount of axial force, along with a twisting motion, caused the pacing lead, with failed insulation, to lacerate the sheath. This situation can occur if tension is not kept on the lead or in the instance of an acute bend of the vasculature, the sheath is not oriented with the electrode to the inside of the bend. These situations are addressed in the ifu of the perfecta eds.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2522007-2006-00005 |
| MDR Report Key | 758592 |
| Report Source | 08 |
| Date Received | 2006-08-30 |
| Date of Report | 2006-08-21 |
| Date of Event | 2006-08-02 |
| Date Mfgr Received | 2006-08-03 |
| Device Manufacturer Date | 2005-12-01 |
| Date Added to Maude | 2006-09-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | THOMAS KARDOS |
| Manufacturer Street | 1186 MONTGOMERY LN |
| Manufacturer City | VANDERGRIFT PA 15690 |
| Manufacturer Country | US |
| Manufacturer Postal | 15690 |
| Manufacturer Phone | 7248458621 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LR-PFTA-11.0 |
| Generic Name | LR-PFTA-11.0 |
| Product Code | GCC |
| Date Received | 2006-08-30 |
| Returned To Mfg | 2006-08-21 |
| Model Number | LR-PFTA-11.0 |
| Catalog Number | LR-PFTA-11.0 |
| Lot Number | N62138 |
| ID Number | G26579 |
| Device Expiration Date | 2008-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 746516 |
| Manufacturer | COOK VASCULAR INC. |
| Manufacturer Address | * VANDERGRIFT PA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2006-08-30 |