MAUDE Adverse Event Report: HOLOGIC, INC. DEFINITY CERVICAL DILATOR, 7MM; 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 10/14/2020

Event Type  Injury  

Manufacturer Narrative

Device history record (dhr) review was conducted for the reported identification number.The lot was released meeting all qa specifications.The device has not yet been returned therefore, a failure analysis of the complaint device cannot be completed.If the device is returned and evaluation completed, a supplemental medwatch will be filed.

Event Description

It was reported that on (b)(6) 2020 a procedure was performed with patient under general anesthesia using a definity cervical dilator to gain access to the uterus.The patient was post menopausal with stenotic tissue and at a previous appointment for endometrial sampling.Doctor could not gain access to the uterus.Doctor inserted the myosure scope after using the second definity device into the os doctor noted a perforation in the cervical canal and viewed bowel.Doctor removed the myosure scope and used a pipelle to obtain tissue sample.Completed the sampling without treatment for the perforation and no additional details available about current status of the patient.

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.Standard dhr review a device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.We are currently unable to establish a relationship between the device and the issue reported.

• Brand Name: DEFINITY CERVICAL DILATOR, 7MM
• Type of Device: CATHETER, BALLOON, DILATION OF CERVICAL CANAL
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 10823555
• MDR Text Key: 215951736
• Report Number: 1222780-2020-00147
• Device Sequence Number: 1
• Product Code: PON
• UDI-Device Identifier: 35420045512423
• UDI-Public: (01)35420045512423(10)20F04RQ(17)210704
• 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,health
• Type of Report: Initial,Followup
• Report Date: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/04/2021
• Device Model Number: DCD-701
• Device Catalogue Number: DCD-701
• Device Lot Number: 20F04RQ
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MYOSURE HYSTEROSCOPE
• Patient Outcome(s): Other