MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-26 for AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB) MOB37 manufactured by W.l. Gore & Associates.
[185614817]
Pma/510(k) #k172567. A review of the manufacturing records for the device(s) verified that the lot(s) met all pre-release specifications.
Patient Sequence No: 1, Text Type: N, H10
[185614818]
On (b)(6) 2020, this patient underwent endovascular treatment for an abdominal aortic aneurysm and was implanted with gore? Excluder? Aaa endoprostheses featuring? Delivery system. The trunk ipsilateral leg component was advanced into position via a gore? Dryseal flex introducer sheath; however when deployed, the introducer sheath had not been completely withdrawn back to the light colored shaft marker on the delivery catheter and the ipsilateral leg deployed within the sheath. The physician then chose to cannulate the contralateral gate with the sheath still in place but met with difficulty due to the narrowness of the date due to patient anatomy. After multiple attempts, successful cannulation of the gate was achieved and the delivery catheter was removed from the patient. The physician then cut the trailing end of the (locking mechanism) of the dilator of the sheath and inserted it from the trailing and pushed the ipsilateral leg out of the sheath and successfully deployed in the left common iliac artery. Post deployment of all the devices touch up angioplasty was performed throughout the entire system with a gore? Molding & occlusion balloon. Final angiography was performed and identified a type ii endoleak and a dissection immediately proximal to the trunk. A gore? Aortic extender component was implanted proximally to extend coverage and treat the dissection. At the conclusion of the procedure a slight dissection remained. The physician reported that the dissection may have been caused by calcification in the patient's proximal neck, touch up angioplasty and the complications associated with the ipsilateral leg deployment. The patient tolerated the procedure and will be monitored by the physician.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007284313-2020-00079 |
| MDR Report Key | 9886843 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-03-13 |
| Device Manufacturer Date | 2019-10-10 |
| Date Added to Maude | 2020-03-26 |
| 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 | LAURA CRAWFORD |
| Manufacturer Street | 1500 N. 4TH STREET |
| Manufacturer City | AZ |
| Manufacturer Phone | 9285263030 |
| Manufacturer G1 | MEDICAL PHOENIX 1 B/P |
| Manufacturer Street | 32360 N. NORTH VALLEY PARKWAY |
| Manufacturer City | PHOENIX AZ 85085 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 85085 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB) |
| Generic Name | CATHETER, PERCUTANEOUS |
| Product Code | DQY |
| Date Received | 2020-03-26 |
| Model Number | MOB37 |
| Catalog Number | MOB37 |
| Lot Number | 21409738 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | W.L. GORE & ASSOCIATES |
| Manufacturer Address | FLAGSTAFF AZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2020-03-26 |