MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-07-28 for RELIEVA SOLO PRO 6 X 16 MM BALLOON CATHETER 6X16MM BC0616SP manufactured by .
[2595236]
This event occurred during a procedure performed on (b)(6) 2011, with no injury associated. Acclarent received a complaint for difficult device insertion on (b)(6) 2011. The device was returned on (b)(4) 2011, and evaluated on (b)(4) 2011. Acclarent confirmed the device to be excessively manipulated by the user, as described in the complaint report. Multiple kinks in the flexible shaft, a damaged metal hypotube, and 2 missing adhesive fillets were noted. Due to a similar malfunction associated with a missing fillet within 2 years ((b)(4) 2011), this complaint has been deemed reportable. Note: the fillets are conical/tubular in appearance, and are approx 1 x 1 mm in size. Both the distal and proximal do not provide structural support. Their function is to provide a smooth transition between the flexible shaft and the balloon.
Patient Sequence No: 1, Text Type: D, B5
[9747272]
With regard to fillet detachment, a through investigation into the associated materials, method/process, environmental controls, historical data, probable root cause, and product impact has been performed. No contributing issues were identified. As of (b)(4) 2011, the solo pro complaint rate for this failure has been noted as 0. 003%. No design changes/modifications to solo pro device has been made since its introduction. The suspected root cause for the detachment of the fillet is that the device encountered excessive force/manipulation/kinking upon multiple insertions, which compromised the fillet bonds shared with the shoulder of the balloon/balloon shaft. Note, all solo pro fillet bonds are 100% inspected. In addition, no distal adhesive fillet detachments have been noted during lot testing from solo pro's launch in october 2008, to present. Acclarent will continue to update the file with any additional info and provide subsequent reports if required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005172759-2011-00007 |
| MDR Report Key | 2506733 |
| Report Source | 07 |
| Date Received | 2011-07-28 |
| Date of Report | 2011-07-28 |
| Date of Event | 2011-06-23 |
| Device Manufacturer Date | 2011-01-01 |
| Date Added to Maude | 2012-06-21 |
| 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 | RISK MANAGER |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARK BISHOP, VP |
| Manufacturer Street | 1525-B O'BRIEN DR. |
| Manufacturer City | MENLO PARK CA 94025 |
| Manufacturer Country | US |
| Manufacturer Postal | 94025 |
| Manufacturer Phone | 6506875843 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RELIEVA SOLO PRO 6 X 16 MM BALLOON CATHETER |
| Generic Name | SOLO PRO |
| Product Code | KAM |
| Date Received | 2011-07-28 |
| Returned To Mfg | 2011-07-11 |
| Model Number | 6X16MM |
| Catalog Number | BC0616SP |
| Lot Number | 110105D-CM |
| Device Expiration Date | 2013-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-07-28 |