MAUDE Adverse Event Report: HOLOGIC, INC. DEFINITY CERVICAL DILATOR, 5MM; CATHETER, BALLOON, DILATION OF CERVICAL CANAL

Model Number DCD-501

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Uterine Perforation (2121)

Event Date 01/13/2021

Event Type  Injury  

Manufacturer Narrative

Lot and serial number of the device not provided by the complainant; therefore, the udi, expiration and manufacturing dates are not known.Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.

Event Description

It was reported that during a procedure for cervical dilation a physician used manual dilators and a definity cervical 5mm dilator during the procedure a uterine perforation was observed.No other information is available.

Manufacturer Narrative

Conclusion by sme.· appears fluid was able to get to the membrane and dilation balloon, the membrane was ruptured and the dilation balloon could hold pressure, but fluid was leaking at the luer connector on the proximal handle when pressurized.The dilation balloon could not be extended beyond the acorn tip - this observation will be monitored and trended.A device history record (dhr) review could not be conducted as the lot/serial number was not provided by the complainant or the product is non traceable.

• Brand Name: DEFINITY CERVICAL DILATOR, 5MM
• Type of Device: CATHETER, BALLOON, DILATION OF CERVICAL CANAL
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough, MA 01752
• MDR Report Key: 11259048
• MDR Text Key: 229636515
• Report Number: 1222780-2021-00007
• Device Sequence Number: 1
• Product Code: PON
• Combination Product (y/n): N
• PMA/PMN Number: K190813
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DCD-501
• Device Catalogue Number: DCD-501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Initial Date Manufacturer Received: 01/13/2021
• Initial Date FDA Received: 02/01/2021
• Supplement Dates Manufacturer Received: 01/13/2021
• Supplement Dates FDA Received: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other