MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-04-03 for LEAD EXTRACTION BYRD POLYPROPYLENE DILATOR SHEATH SET N/A LR-PPLBES-10.0 manufactured by Cook Vascular Inc..
[104171570]
Common name: dilator, catheter. Product code: gcc. (b)(4). This event is currently under investigation. A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[104171571]
A cook sales representative reported a cook polypropylene sheath was used during a procedure. The heart lead came out with the cook sheath but there was a slow pericardial effusion. A heart lead was re-implanted but the effusion continued to grow. The patient required an additional procedure. A sternotomy was performed to repair a small tear between the ra and rv. No unintended section of the device remained inside the patient's body. The patient was recovering well and discharged accordingly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2522007-2018-00013 |
| MDR Report Key | 7391877 |
| Report Source | OTHER |
| Date Received | 2018-04-03 |
| Date of Report | 2018-11-26 |
| Date of Event | 2018-02-27 |
| Date Mfgr Received | 2018-03-05 |
| Date Added to Maude | 2018-04-03 |
| 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 | MR. BRIAN JOHNSTON |
| Manufacturer Street | 1186 MONTGOMERY LANE |
| Manufacturer City | VANDERGRIFT PA 15690 |
| Manufacturer Country | US |
| Manufacturer Postal | 15690 |
| Manufacturer Phone | 4128458621 |
| Manufacturer G1 | COOK VASCULAR INC |
| Manufacturer Street | 1186 MONTGOMERY LANE |
| Manufacturer City | VANDERGRIFT PA 15690 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 15690 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEAD EXTRACTION BYRD POLYPROPYLENE DILATOR SHEATH SET |
| Product Code | GCC |
| Date Received | 2018-04-03 |
| Model Number | N/A |
| Catalog Number | LR-PPLBES-10.0 |
| Lot Number | UNKNOWN |
| 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 | 2018-04-03 |