DS BREAST ADAPTIVE 16CH MR COIL - DSTREAM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-09 for DS BREAST ADAPTIVE 16CH MR COIL - DSTREAM manufactured by Invivo Corporation.

Event Text Entries

[126646213] The design of the philips 16 channel adaptive coil is completely unacceptable for purposes of biopsy. We are one of few sites in the country with developing breast imaging and biopsy programs utilizing philips mri systems with invivo breast imaging coils and another biopsy systems. We have worked with applications for long extended periods of time from each company and have come to a determination that the philips/invivo 16 channel adaptive coil that is marketed and was sold to us as a combo diagnostic imaging/biopsy coil that would suit 100% of our needs is false. The diagnostic imaging portion is acceptable, but for biopsy it is very below the standard for patient care. The manual and software calculations for the biopsy targeting are so off that at least 4 of 5 attempts into a phantom the biopsy mass was missed completely. We have refused to use the coil and biopsy system on actual patients. The 16 channel coil is the problem and is not designed or adapted for successful biopsy like it's marketed and sold. We met with philips and they said in europe it's been pulled from the market and the sales rep told us he won't sell the coil to customers anymore. Manufacturer response for coil, magnetic resonance, specialty (breast), ds breast adaptive 16ch mr coil (per site reporter). The manufacturer acknowledged the issue, stated that they fully understand our position and that additional applications training would not solve the issue; however, refused return of the coil, but offered quote for a different product.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8054580
MDR Report Key8054580
Date Received2018-11-09
Date of Report2018-11-05
Date of Event2018-10-01
Report Date2018-11-05
Date Reported to FDA2018-11-05
Date Reported to Mfgr2018-11-09
Date Added to Maude2018-11-09
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationBIOMEDICAL ENGINEER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDS BREAST ADAPTIVE 16CH MR COIL - DSTREAM
Generic NameCOIL, MAGNETIC RESONANCE, SPECIALTY
Product CodeMOS
Date Received2018-11-09
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerINVIVO CORPORATION
Manufacturer Address3545 SW 47TH AVE GAINESVILLE FL 32608 US 32608


Patients

Patient NumberTreatmentOutcomeDate
10 2018-11-09

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.