MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,health professional report with the FDA on 2015-08-03 for FG GATEWAY OTW US 2.00MM X 9MM M0032072209200 manufactured by Boston Scientific - Minn.
[6640316]
Coil embolization was performed to treat a ruptured basilar tip aneurysm and subsequent subarachnoid hemorrhage (sah) the patient presented with. During the procedure, thrombus was noted in the left internal carotid artery (ica) and the right posterior cerebral artery (pca). Intra-arterially 6mg of intregrillin was given to the patient and the left ica clot was resolved. However, there was a persistent filling defect due to persistent clot in the right p1 pca origin. It was reported that angioplasty using the subject balloon was performed to treat a right p1 posterior cerebral artery occlusion. After the angioplasty, minimal residue clot was noted in the distal pca without flow limitation and the proximal p1 pca clot was resolved. Procedure was completed and the patient was transferred to the neurovascular intensive care. The patient slowly was improving over the next couple of days. However, three days post procedure the patient had some confusion. The imaging showed sah and possible hydrocephalus. The next day, the patient was hallucinating and increased restlessness. The patient was given pepcid, heparin (d/c 6am (b)(6) 2015) nimodipine, docustate sodium, lisinopril, apap-oxycodone, hydromorphine, nicotine, phenergan, potassium, dexmedetomidine. The patient condition continued to deteriorate with decreasing level of consciousness. The patient respiratory arrested and died. The physician determined the cause of death as brain herniation due to hydrocephaly.
Patient Sequence No: 1, Text Type: D, B5
[13515375]
The device is not available to the manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[24997223]
The device history record review confirms that the device met all material, assembly and performance specifications. The device was not available for analysis. From the information provided there was no indication that the device was not used as in accordance with the labeling or that this caused or contributed to the reported event. Death is a known and anticipated complication to these types of procedures and patient condition, and is noted in the labeling. Therefore, it was determined that the reported event was an anticipated patient complication.
Patient Sequence No: 1, Text Type: N, H10
[24997224]
Coil embolization was performed to treat a ruptured basilar tip aneurysm and subsequent subarachnoid hemorrhage (sah) the patient presented with. During the procedure, thrombus was noted in the left internal carotid artery (ica) and the right posterior cerebral artery (pca). Intra-arterially 6mg of intregrillin was given to the patient and the left ica clot was resolved. However, there was a persistent filling defect due to persistent clot in the right p1 pca origin. It was reported that angioplasty using the subject balloon was performed to treat a right p1 posterior cerebral artery occlusion. After the angioplasty, minimal residue clot was noted in the distal pca without flow limitation and the proximal p1 pca clot was resolved. Procedure was completed and the patient was transferred to the neurovascular intensive care. The patient slowly was improving over the next couple of days. However, three days post procedure the patient had some confusion. The imaging showed sah and possible hydrocephalus. The next day, the patient was hallucinating and increased restlessness. The patient was given pepcid, heparin (d/c 6am 7/8/15) nimodipine, docustate sodium, lisinopril, apap-oxycodone, hydromorphine, nicotine, phenergan, potassium, dexmedetomidine. The patient condition continued to deteriorate with decreasing level of consciousness. The patient respiratory arrested and died. The physician determined the cause of death as brain herniation due to hydrocephaly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008853977-2015-00325 |
| MDR Report Key | 4961605 |
| Report Source | 05,HEALTH PROFESSIONAL |
| Date Received | 2015-08-03 |
| Date of Report | 2015-07-14 |
| Date of Event | 2015-07-11 |
| Date Mfgr Received | 2015-08-18 |
| Device Manufacturer Date | 2014-07-16 |
| Date Added to Maude | 2015-08-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. KATHLEEN SHIN |
| Manufacturer Street | 47900 BAYSIDE PARKWAY |
| Manufacturer City | FREMONT CA 94538 |
| Manufacturer Country | US |
| Manufacturer Postal | 94538 |
| Manufacturer Phone | 5104132500 |
| Manufacturer G1 | BOSTON SCIENTIFIC - MINN |
| Manufacturer Street | ONE SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55311 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FG GATEWAY OTW US 2.00MM X 9MM |
| Generic Name | CATHETER, BALLOON TYPE |
| Product Code | PAV |
| Date Received | 2015-08-03 |
| Catalog Number | M0032072209200 |
| Lot Number | 17022074 |
| Device Expiration Date | 2016-07-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - MINN |
| Manufacturer Address | ONE SCIMED PLACE MAPLE GROVE MN 55311 US 55311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2015-08-03 |