MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-25 for PREFORM GUIDEWIRE - SAFARI2 manufactured by Lake Region Medical.
[185704464]
The end user did not provide lot traceability for the safari2 guidewire. The lack of lot traceability prevents performing a device history records review for any indication of manufacturing defect or anomaly that could have impacted on the event as reported. A review of the manufacturing processes indicates that during manufacturing and packaging of this product the operators are instructed to 100% visually inspect for any obvious defect prior to shipment. The device was not received for analysis; therefore no physical or visual analysis of the product could be performed. Review of the directions for use lists arrhythmia as a potential adverse event associated with the tavr/tavi procedure. Based on the information provided, it appears that clinical and/or procedural factors may have contributed to the event as reported. At this time, it is not possible to assign a definitive root cause for the event as reported. Should additional information be provided or product be returned for analysis a follow-up medwatch report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[185704467]
As reported by the distributor: event description: per email, it was reported that: pacemaker implanted post procedure. Additional information received: what event necessitated a need for a pacemaker? As soon as the safari wire went across annulus the patient went into heart block. Was a pacemaker successfully implanted? Yes post procedure. What is the patients current condition? As far as i am aware stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2126666-2020-00026 |
| MDR Report Key | 9880190 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-13 |
| Date Added to Maude | 2020-03-25 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. JACKIE OHNSORG |
| Manufacturer Street | 340 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA, MN |
| Manufacturer Country | US |
| Manufacturer Phone | 6418516 |
| Manufacturer G1 | LAKE REGION MEDICAL |
| Manufacturer Street | 340 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA, MN |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PREFORM GUIDEWIRE - SAFARI2 |
| Generic Name | WIRE GUIDE |
| Product Code | DQX |
| Date Received | 2020-03-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LAKE REGION MEDICAL |
| Manufacturer Address | 340 LAKE HAZELTINE DRIVE CHASKA, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-25 |