MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-28 for COMANECI ANPP7177 manufactured by Rapid-medical Ltd.
[176649400]
Manufacturer narrative: the device has not been returned for evaluation, however, device history record (dhr) review confirmed that the device met all material assembly and performance specifications. In addition, the provided information indicates that the device operated as expected and the event is not associated to device manufacturing or design issues. Coils entanglement is a known potential complication associated with the use of the comaneci and other coils embolization assist devices , the instruction for use (ifu) contains recommendation to verify the coil's stability in the aneurysm by deflating the device before coil detachment in order to prevent coils entanglement. The root cause cannot be conclusively determined; however, according to physician report, it is possible that the aneurysm square structure and aneurysms size (height of 4mm, neck of 3. 5mm and width of 3. 5mm) may have contributed to the reported event. Based on the above, it is possible that procedural and handling factors may have contributed to the reported event. Corrected data: this report was late due to the webtrade enrollment process, the company purchased digital certificate from comsign as recommended at https://www. Fda. Gov/industry/about-esg/esg-appendix-c-digital-certificates), the comsign certificate that the company bought was approved for the registration of rapid medical webtrader account, however, once the company tried to submit the demo mdr, it was found out that comsign service cannot provide. P12 private key as required. Therefore, the company need to contact anther digital certificate supplier (out of israel) that is able to provide the required certificate.
Patient Sequence No: 1, Text Type: N, H10
[176649401]
Rapid medical received report that coils got tangled in the comaneci embolization assist device. This event occurred during a comaneci assisted coiling of a right ophthalmic aneurysm. The comaneci performed as intended, however, coils got tangled in the device. The physician attempted several times to release the tangled coils by opening and closing device mesh without success. Therefore, lvis stent was deployed distal to the comaneci, once the lvis stent was placed, the physician closed the comaneci mesh and the herniated coils end were pressed against the vessel wall. The procedure was successfully completed without any further issues. The physician recognized it was a technical error. The patient did not experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009957947-2020-00002 |
| MDR Report Key | 9636460 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-28 |
| Date of Report | 2020-01-27 |
| Date of Event | 2019-11-27 |
| Date Mfgr Received | 2019-12-03 |
| Device Manufacturer Date | 2019-06-16 |
| Date Added to Maude | 2020-01-28 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS ORIT YANIV |
| Manufacturer Street | CARMEL BUILDING, POB 337 |
| Manufacturer City | YOKNEAM, ISRAEL 2069205 |
| Manufacturer Country | IS |
| Manufacturer Postal | 2069205 |
| Manufacturer G1 | RAPID-MEDICAL LTD |
| Manufacturer Street | CARMEL BUILDING, POB 337 |
| Manufacturer City | YOKNEAM, 2069205 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 2069205 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMANECI |
| Generic Name | COMANECI |
| Product Code | PUU |
| Date Received | 2020-01-28 |
| Model Number | ANPP7177 |
| Catalog Number | ANPP7177 |
| Lot Number | 190616CC01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RAPID-MEDICAL LTD |
| Manufacturer Address | CARMEL BUILDING, POB 337 YOKNEAM, 2069205 IS 2069205 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2020-01-28 |