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 2020-01-14 for RELIEVA SPIN PLUS KIT, 3 GUIDES, 6MM, 5PK RSP0616MFS manufactured by Acclarent, Inc..
[175850044]
Manufacturer? S ref. No: (b)(4). Information regarding patient identifier, date of birth, weight, race, ethnicity, and medical history were not provided. [conclusion]: the healthcare professional reported that during a primary balloon sinuplasty (bsp) procedure on (b)(6) 2019, targeting the frontal, maxillary, and sphenoid sinuses, the frontal guide catheter tip on the 6mm 3 guides relieva spinplus kit (rsp0616mfs / 190627a-pc) cracked when it was inserted into the patient? S nasal cavity. It was reported that the tip cracked but did not become separated from the rest of the guide catheter. No pieces fell into or were left in the patient? S anatomy. The physician verified using the endoscope (stryker) and confirmed that there was no particle left in the patient. The device was replaced with another 6mm 3 guides relieva spinplus kit (rsp0616mfs), and the physician completed the procedure. There was no report of any patient adverse event or complication. The product was returned for evaluation and analysis. The investigational finding is documented below. Investigation summary: acclarent received the returned package on 1/14/2020. The package was comprised of the following: relieva spin plus, guide catheters (s-0, f-70, and m-110). Before decontamination, the product and its components were visually inspected. The s-0 and m-100 guide catheters were observed without any damage. The f-70, the plastic distal portion frontal guide catheter was observed broken with a crack/fracture near the steel shaft; the break was not complete as it was still connected to the rest of the guide catheter. The returned device underwent a two-hour decontamination in a 10% bleach solution after the visual inspection. The lot history record (lhr) was reviewed for this lot (190627a-pc). There were no anomalies found related to this complaint. In addition, the lhr review verified that the device was manufactured in accordance with documented specification and procedures. The issue documented in the complaint that the frontal guide catheter tip was cracked when it was inserted into the patient? S nasal cavity was confirmed with the visual inspection performed on the returned device. Based on the device lot history record review, there is no indication that the event is related to the device manufacturing process. The exact cause of the reported issue could not be conclusively determined; however, it is possible that circumstances of the procedure and / or device manipulation / interaction may have contributed to the reported failure. As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective/preventive action may be triggered at a later time. Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time. Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission. 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
[175850045]
The healthcare professional reported that during a primary balloon sinuplasty (bsp) procedure on (b)(6) 2019, targeting the frontal, maxillary, and sphenoid sinuses, the frontal guide catheter tip on the 6mm 3 guides relieva spinplus kit (rsp0616mfs / 190627a-pc) cracked when it was inserted into the patient? S nasal cavity. It was reported that the tip cracked but did not become separated from the rest of the guide catheter. No pieces fell into or were left in the patient? S anatomy. The physician verified using the endoscope (stryker) and confirmed that there was no particle left in the patient. The device was replaced with another 6mm 3 guides relieva spinplus kit (rsp0616mfs), and the physician completed the procedure. There was no report of any patient adverse event or complication.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005172759-2019-00125 |
| MDR Report Key | 9589485 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-14 |
| Date of Report | 2019-12-23 |
| Date of Event | 2019-12-20 |
| Date Mfgr Received | 2019-12-23 |
| Device Manufacturer Date | 2019-06-27 |
| Date Added to Maude | 2020-01-14 |
| 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 | 31 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 949789-868 |
| Manufacturer G1 | ACCLARENT, INC. |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 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 | 2020-01-14 |
| Returned To Mfg | 2020-01-14 |
| 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 | 2020-01-14 |