FDA.reportPublic FDA data

MAUDE MDR 8277477

MDR report key
8277477
Report number
1820334-2019-00202
Event key
0
Event type
3
Date received
2019-01-25
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. LARRY POOL
Address
750 DANIELS WAY BLOOMINGTON IN 47404 US
Phone
812-812-8123
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1COOK CERVICAL RIPENING BALLOON W/STYLETPFJ, DILATOR, CERVICAL, HYGROSCOPIC-IAMINARIACOOK INCPFJJ-CRBS-1840009227883Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-01-250

Event Narratives#

N

Patient 1

THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

D

Patient 1

IT WAS INITIALLY REPORTED DURING A CERVICAL RIPENING PROCEDURE, THE STYLET PERFORATED THE SIDE WALL OF THE CATHETER WHICH PROVED PAINFUL FOR THE PATIENT. SUBSEQUENT INVESTIGATION WITHIN THE HOSPITAL HAS IDENTIFIED A TRAINING NEED AS THE MEMBER OF STAFF WAS UNTRAINED AND NOT FOLLOWING THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS REMOVED, A NEW BALLOON WAS INSERTED BY A TRAINED MEMBER OF STAFF AND THERE WAS NO FURTHER INCIDENT. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE COOK REPRESENTATIVE ON 25JAN2019. FOLLOWING DISCUSSIONS WITH THE HOSPITAL TODAY, WE HAVE ESTABLISHED THIS IS A TRAINING ISSUE RATHER THAN A FAULTY DEVICE. THE MEMBER OF STAFF CONCERNED HAD NEVER USED THE DEVICE BEFORE, HAD NOT ATTENDED ANY TRAINING AND DID NOT FOLLOW THE IFU THAT ENSURES THE DISTAL TIP OF THE STYLET WAS FIRMLY SEATED IN THE DISTAL TIP OF THE CATHETER. SHE WAS UNAWARE THAT THE STYLET NEEDED TO BE FIXED IN PLACE. THEY HAD BASIC INSTRUCTION FROM ANOTHER MEMBER OF STAFF. WHEN THE STYLET PERFORATED THE SIDE WALL OF THE CATHETER IT WAS UNDERSTANDABLY PAINFUL FOR THE PATIENT. THE DEVICE WAS REMOVED, ANOTHER MEMBER OF STAFF (MIDWIFE) INSERTED A NEW BALLOON AND THE PATIENT WENT ON TO SVD WITHOUT ANY FURTHER ISSUES.