MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-06-15 for PROVOX VEGA PUNCTURE SET 17FR 8MM 8140 manufactured by Atos Medical Ab.
[77614808]
Investigation: no products were returned to atos medical ab, therefore the investigation is based on the information in the complaint report together with a picture taken at the hospital. Information from complaint report: "on examination of removed valve slp noticed an extra bit/foreign object similar in appearance to valve securement sitting around the barrel of the valve in the tof. The foreign object was identified as part of the securement device loop of the valve from the primary puncture kit. Picture taken and shown to the ent reg who did his primary puncture and she admitted to the slp that at the end they weren't sure how to remove the ring even though they were going through instructions step by step. " internal investigation: the ifu and the illustrations have been reviewed to see if any deviations could be found. The illustrations 2. 11 and 2. 12 clearly show that the loop should be removed. Conclusion/action: no product fault was found. Device is not available for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[77614809]
This is the information that was received from the atos medical local representative: slp removed valve due to onset of peripheral leakage. (valve inserted (b)(6) 2017)(reported (b)(6) 2017) on examination of removed valve slp noticed an extra bit/foreign object similar in appearance to valve securement sitting around the barrel of the valve in the tof. The foreign object was identified as part of the securement device loop of the valve from the primary puncture kit. Picture taken and shown to the ent reg who did his primary puncture and she admitted to the slp that at the end they weren't sure how to remove the ring even though they were going through instructions step by step. ? Atos was not consulted about this particular procedure or asked to attend or provide education or education material. The step by step instructions the surgeon followed are also not available to review. Surgeon offered ongoing and further education and resources and case support for next and future cases. As per slp, patient not compromised or no adverse event recorded.
Patient Sequence No: 1, Text Type: D, B5
[116937663]
Investigation: no products were returned to atos medical (b)(4), therefore the investigation is based on the information in the complaint report together with a picture taken at the hospital. Information from complaint report: "on examination of removed valve slp noticed an extra bit/foreign object similar in appearance to valve securement sitting around the barrel of the valve in the tof. The foreign object was identified as part of the securement device loop of the valve from the primary puncture kit. Picture taken and shown to the ent reg who did his primary puncture and she admitted to the slp that at the end they weren't sure how to remove the ring even though they were going through instructions step by step. " internal investigation: the ifu and the illustrations have been reviewed to see if any deviations could be found. The illustrations 2. 11 and 2. 12 clearly show that the loop should be removed. Conclusion/action: no product fault was found. Device is not available for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[116937664]
This is the information that was received from the atos medical local representative: slp removed valve due to onset of peripheral leakage. (valve inserted (b)(6) 2017)( reported may 5th 2017) on examination of removed valve slp noticed an extra bit/foreign object similar in appearance to valve securement sitting around the barrel of the valve in the tof. The foreign object was identified as part of the securement device loop of the valve from the primary puncture kit. Picture taken and shown to the ent reg who did his primary puncture and she admitted to the slp that at the end they weren't sure how to remove the ring even though they were going through instructions step by step. Atos was not consulted about this particular procedure or asked to attend or provide education or education material. The step by step instructions the surgeon followed are also not available to review. Surgeon offered ongoing and further education and resources and case support for next and future cases. As per slp, patient not compromised or no adverse event recorded.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8032044-2017-00008 |
| MDR Report Key | 6642720 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-06-15 |
| Date of Report | 2017-05-11 |
| Date of Event | 2017-05-11 |
| Date Mfgr Received | 2017-05-11 |
| Date Added to Maude | 2017-06-15 |
| 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 | SPEECH THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. KAROLINA NILSSON |
| Manufacturer Street | KRAFTGATAN 8 |
| Manufacturer City | HORBY, SE-24222 |
| Manufacturer Country | SW |
| Manufacturer Postal | SE-24222 |
| Manufacturer Phone | 641519800 |
| Manufacturer G1 | ATOS MEDICAL AB |
| Manufacturer Street | KRAFTGATAN 8 |
| Manufacturer City | HORBY, SE-24222 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | SE-24222 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROVOX VEGA PUNCTURE SET 17FR 8MM |
| Generic Name | VOICE PROSTHESIS |
| Product Code | EWL |
| Date Received | 2017-06-15 |
| Catalog Number | 8140 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 0 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ATOS MEDICAL AB |
| Manufacturer Address | KRAFTGATAN 8 HORBY, SE-24222 SW SE-24222 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-15 |