MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-10-22 for RELIEVA SPIN PLUS KIT, 3 GUIDES, 6MM, 5PK RSP0616MFS manufactured by Acclarent, Inc..
[126243075]
Manufacturer? S ref. No: (b)(4). Information regarding patient age, gender, weight, race, ethnicity, and medical history were not provided. [conclusion]: the healthcare professional reported that during the primary functional endoscopic sinus surgery (fess) procedure on (b)(6) 2018, the clear plastic portion on frontal guide catheter that is part of the relieva spinplus kit, 3 guides, 6mm (rsp0616mfs / 180312a-pc) became cracked / broken during the treatment of the left frontal sinus. Per the acclarent sales representative, the patient? S anatomy was challenging to maneuver around; the plastic portion on the guide catheter broke but did not become separated from the guide catheter shaft. The spinplus balloon catheter had been inflated two to three times before the issue with the frontal guide catheter occurred. The physician had performed a septoplasty before the attempt to treat the left frontal sinus. The spinplus balloon catheter was replaced and the procedure was resumed and subsequently completed. There was no report of any patient injury or adverse event associated with the reported issue. The device was returned for analysis. The investigational finding is documented below. The lot history record (lhr) was reviewed for lot 180312a-pc. No anomalies were found related to this complaint. In addition, the lhr review verifies that the device was manufactured in accordance with documented specification and procedures. Acclarent received the returned package on 10/16/2018, which included the relieva spinplus kit and the f-70 frontal guide catheter. Before undergoing decontamination, the returned device was visually inspected. It was noted that the guide catheter has a broken plastic tip; the area of damage is located at the clear plastic portion on the guide catheter. The broken piece is still attached to the guide catheter; no piece became separated. The returned device underwent decontamination. After decontamination, the spinplus device was tested; there was no advancing / retracting issues noted with the guide wire or the balloon catheter. The customer reported issue related to the guide catheter being broken was confirmed. With the information provided in the complaint and the returned device for investigation, the issue reported that the frontal guide catheter broke during the procedure but did not become separated from the shaft of the guide catheter was confirmed. Based on the lot history record (lhr) review, there is no indication that the event is related to the device manufacturing process. The exact cause of the failure could not be conclusively determined; however, it was reported that the patient? S anatomy was challenging to maneuver around. This could likely have caused the clear plastic portion of the guide catheter to break while the physician was trying to maneuver around the patient? S anatomy. The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report. Additional information will be submitted within 30 days of receipt.
Patient Sequence No: 1, Text Type: N, H10
[126243076]
The healthcare professional reported that during the primary functional endoscopic sinus surgery (fess) procedure on (b)(6) 2018, the clear plastic portion on frontal guide catheter that is part of the relieva spinplus kit, 3 guides, 6mm (rsp0616mfs / 180312a-pc) became cracked / broken during the treatment of the left frontal sinus. Per the acclarent sales representative, the patient? S anatomy was challenging to maneuver around; the plastic portion on the guide catheter broke but did not become separated from the guide catheter shaft. The spinplus balloon catheter had been inflated two to three times before the issue with the frontal guide catheter occurred. The physician had performed a septoplasty before the attempt to treat the left frontal sinus. The spinplus balloon catheter was replaced and the procedure was resumed and subsequently completed. There was no report of any patient injury or adverse event associated with the reported issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005172759-2018-00114 |
| MDR Report Key | 7992782 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-10-22 |
| Date of Report | 2018-10-02 |
| Date of Event | 2018-10-02 |
| Date Mfgr Received | 2018-10-02 |
| Device Manufacturer Date | 2018-03-12 |
| Date Added to Maude | 2018-10-22 |
| 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 | MR. GABRIEL ALFAGEME |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 949789-868 |
| Manufacturer G1 | ACCLARENT, INC. |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RELIEVA SPIN PLUS KIT, 3 GUIDES, 6MM, 5PK |
| Generic Name | INSTRUMENT, ENT MANUAL SURGICAL |
| Product Code | LRC |
| Date Received | 2018-10-22 |
| Returned To Mfg | 2018-10-16 |
| Catalog Number | RSP0616MFS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACCLARENT, INC. |
| Manufacturer Address | 33 TECHNOLOGY DRIVE IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-22 |