FDA.reportPublic FDA data

MAUDE MDR 9559325

MDR report key
9559325
Report number
2134265-2019-15879
Event key
0
Event type
3
Date of event
2019-12-05
Date received
2020-01-07
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
JAY JOHNSON
Address
TWO SCIMED PLACE MAPLE GROVE MN 55311 US
Phone
763-763-7634
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1COMETTRANSDUCER, PRESSURE, CATHETER TIPBOSTON SCIENTIFIC CORPORATIONDXO890089000024100281Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-070

Event Narratives#

N

Patient 1

DEVICE RETURNED TO MANUFACTURER: THE COMET WAS RETURNED WITHOUT THE HANDLE AND ANALYSIS WAS COMPLETED. THE TIP, DEVICE SHAFT AND SENSOR PORT WERE EXAMINED FOR DAMAGE OR ANY IRREGULARITIES. THE INVESTIGATION OF THE SHAFT OF THE DEVICE SHOWED NO DAMAGE. THE TIP SHOWED A BEND. IT WAS NOTICED THAT THERE WAS SOME PEELING OF THE COATING LOCATED 81CM FROM THE TIP AND CONTINUED ALONG THE SHAFT TO 131CM. INSPECTION OF THE REMAINDER OF THE DEVICE, APART FROM THE OBSERVED DAMAGE, REVEALED NO OTHER DAMAGE OR IRREGULARITIES. BECAUSE THERE WAS NO EVIDENCE OF ANY PRODUCT QUALITY DEFICIENCIES, IT WAS CONSIDERED LIKELY THAT THE PEELED COATING AND THE TIP DAMAGE WAS ATTRIBUTABLE TO HANDLING ISSUES; THEREFORE, THE CONCLUSION CODE UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT.

D

Patient 1

IT WAS REPORTED THAT FOREIGN MATTER WAS NOTED AFTER A PROCEDURE. A PROCEDURE HAD BEEN COMPLETED WITH THE USE OF A COMET PRESSURE GUIDEWIRE. UPON REMOVING THE COMET FROM THE Y ADAPTOR, IT WAS WIPED WITH A SALINE GAUZE MATERIAL. IT WAS NOTICED THAT A LOT OF BLACK SEDIMENT WAS ON THE GAUZE THEREAFTER. NO INJURY WAS ENCOUNTERED BY THE PATIENT.