MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-11 for STEERABLE GUIDE CATHETER SGC0302 manufactured by Abbott Vascular.
[184445750]
The reported device was not returned for analysis. A review of the lot history record revealed no manufacturing nonconformities. Additionally, a review of the complaint history identified no similar incidents reported from this lot. The reported patient effect of perforation, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedure. All available information was investigated and the cause for reported tear on the steerable guide catheter (sgc) soft tip could not be determined. Perforation appears to be related to procedural circumstances. There is no indication of a product quality issue with respect to manufacture, design or labeling. The additional mitraclip device referenced is being filed under a separate medwatch report.
Patient Sequence No: 1, Text Type: N, H10
[184445751]
This is filed to report soft tip damage and atrial perforation. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 3. An xtr clip delivery system (cds) (91113u102) was advanced and grasping was successfully performed, reducing mr. During deployment of the clip, the gripper line was pulled, but after retracting roughly 1. 3m, the gripper line became stuck. In an attempt to remove the gripper line, the physician decided to remove the cds. However, after removal of the cds, the gripper line was still unable to be removed. Therefore, the physician decided to remove the steerable guide catheter (sgc) (91022u160) and insert a multipurpose catheter to try and remove the gripper line. It was noted that upon removal of the sgc, a slight slit was visible on the soft tip. When attempting to remove the gripper line, addition force was applied, which caused mr to increase. The gripper line was unable to removed, so to reduce mr, an additional clip was implanted while using a separate sgc. The gripper line was left in the patient and a closure the device was used to close the atrial septal defect. There was no clinically significant delay in the procedure. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-02264 |
| MDR Report Key | 9818642 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-02-18 |
| Date Mfgr Received | 2020-02-18 |
| Device Manufacturer Date | 2019-10-22 |
| Date Added to Maude | 2020-03-11 |
| 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 | MS. LINDSEY BELL |
| Manufacturer Street | 26531 YNEZ RD. |
| Manufacturer City | TEMECULA CA 925914628 |
| Manufacturer Country | US |
| Manufacturer Postal | 925914628 |
| Manufacturer Phone | 9519143996 |
| Manufacturer G1 | ABBOTT VASCULAR, REG # 3005070406 |
| Manufacturer Street | 3885 BOHANNON DRIVE |
| Manufacturer City | MENLO PARK CA 94025 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94025 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STEERABLE GUIDE CATHETER |
| Generic Name | VALVE REPAIR |
| Product Code | DRA |
| Date Received | 2020-03-11 |
| Catalog Number | SGC0302 |
| Lot Number | 91022U160 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT VASCULAR |
| Manufacturer Address | 26531 YNEZ RD. TEMECULA CA 925914628 US 925914628 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-11 |