MAUDE Adverse Event Report: HOLOGIC, INC. DEFINITY CERVICAL DILATOR 7 MM; CATHETER, BALLOON, DILATION OF CERVICAL CANAL

Model Number DCD-701

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

Patient Problem Uterine Perforation (2121)

Event Date 03/29/2021

Event Type  Injury  

Manufacturer Narrative

The device involved in this event was not returned for evaluation purposes therefore visual and functional analysis of the product could not be performed.We are unable to confirm a relationship between the device and the issue reported and a definitive root cause for the reported event could not be determined.The information obtained during complaint investigation will be included in our global complaint trending and product surveillance will continue to monitor complaints of this type for adverse trends.If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.Lot and serial number of the device not provided by the complainant; therefore, the udi, expiration and manufacturing dates are not known.

Event Description

It was reported that during a d&c procedure while using a definity dilator, a uterine perforation was suspected, the physician performed a hysteroscopy to check but did not observe a perforation and gave the patient antibiotics for prophylactic treatment.

Manufacturer Narrative

The device involved in this event was not returned for evaluation purposes therefore visual and functional analysis of the product could not be performed.We are unable to confirm a relationship between the device and the issue reported and a definitive root cause for the reported event could not be determined.The information obtained during complaint investigation will be included in our global complaint trending and product surveillance will continue to monitor complaints of this type for adverse trends.If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.

• Brand Name: DEFINITY CERVICAL DILATOR 7 MM
• Type of Device: CATHETER, BALLOON, DILATION OF CERVICAL CANAL
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough, MA 01752
• MDR Report Key: 11619802
• MDR Text Key: 243958723
• Report Number: 1222780-2021-00067
• 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: 04/23/2021

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: No Information
• Device Model Number: DCD-701
• Device Catalogue Number: DCD-701
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/29/2021
• Initial Date FDA Received: 04/06/2021
• Supplement Dates Manufacturer Received: 03/29/2021
• Supplement Dates FDA Received: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other