MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2015-11-10 for LEAD EXTRACTION BULLDOG LEAD EXTENDER N/A LR-LED01 manufactured by Cook Vascular Inc.
[30862936]
The event is currently under investigation.
Patient Sequence No: 1, Text Type: N, H10
[30862937]
During a left-sided laser lead extraction to remove one non-functional rv lead (implanted 17 years). The lead was prepped with a cook bulldog and a 16 glidelight laser sheath was used to extract. The 16f sheath was used and the extraction went smoothly. Using gently traction, the lead was pulled free. A chunk of tissue came free with the lead. An effusion was noted on tee. A sternotomy was performed and an injury at the rv apex was found and repaired. A new bi-v system was implanted and the patient was discharged the next day. Additional information received on 23oct2015: the lead was implanted sometime in 1998 with passive fixation. Lead would not sufficiently take a locking stylet through internal lumen. A bulldog was attached at the proximal (exposed) end of the lead and secured with a one-tie. Another manufacturer's 16fr glidelight was passed over the lead and used to extract lead from the right ventricle, extracting over the majority of the lead body. The lead freed from the wall of the rv taking a chunk of tissue which caused the wall to tear. Patient was put on bypass while chest was opened for repair. The device did not go into the body and the doctor believed this event occurred due to the patient's anatomy and was not device related.
Patient Sequence No: 1, Text Type: D, B5
[54652393]
Investigation/evaluation: during the course of the investigation, a review of the complaint history of the product was conducted. Neither the product nor images were returned. Thus, a full investigation could not be performed. However, based on the complaint report the device did not contact the patient in such a way as to cause the complaint event. There was not any evidence of manufacturing nonconformity or device misuse found. The root cause is unknown. We will continue to monitor for similar complaints. Per the quality engineering risk assessment no further action is required.
Patient Sequence No: 1, Text Type: N, H10
[54652394]
During a left-sided laser lead extraction to remove one non-functional rv lead (implanted 17 years). The lead was prepped with a cook bulldog and a 16 gidelight laser sheath was used to extract. The 16f sheath was used and the extraction went smoothly. Using gently traction, the lead was pulled free. A chunk of tissue came free with the lead. An effusion was noted on tee. A sternotomy was performed and an injury at the rv apex was found and repaired. A new bi-v system was implanted and the patient was discharged the next day. Additional information received on 23oct2015: the lead was implanted sometime in 1998 with passive fixation. Lead would not sufficiently take a locking stylet through internal lumen. A bulldog was attached at the proximal (exposed) end of the lead and secured with a one-tie. Another manufacturer's 16fr glidelight was passed over the lead and used to extract lead from the right ventricle, extracting over the majority of the lead body. The lead freed from the wall of the rv taking a chunk of tissue which caused the wall to tear. Patient was put on bypass while chest was opened for repair. The device did not go into the body and the doctor believed this event occurred due to the patient's anatomy and was not device related.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2015-00737 |
| MDR Report Key | 5213533 |
| Report Source | OTHER |
| Date Received | 2015-11-10 |
| Date of Report | 2015-10-12 |
| Date of Event | 2015-10-12 |
| Date Facility Aware | 2015-10-12 |
| Date Mfgr Received | 2015-10-12 |
| Date Added to Maude | 2015-11-10 |
| 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 | 3 |
| Manufacturer Contact | MRS. RITA HARDEN |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8128294891 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEAD EXTRACTION BULLDOG LEAD EXTENDER |
| Generic Name | HYA FORCEPS, WIRE HOLDING |
| Product Code | HYA |
| Date Received | 2015-11-10 |
| Model Number | N/A |
| Catalog Number | LR-LED01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK VASCULAR INC |
| Manufacturer Address | 1186 MONTGOMERY LANE VANDERGRIFT PA 15690 US 15690 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-11-10 |