MAUDE Adverse Event Report: COOK INC WORD CATHETER SILICONE BARTHOLIN GLAND BALLOON; KNA INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC

Model Number G55442

Device Problems Deflation Problem (1149); Migration (4003)

Patient Problem Scar Tissue (2060)

Event Date 01/18/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported that during the course of treatment for bartholin gland abscess, the patient had a word catheter silicone bartholin gland balloon placed on (b)(6) 2018.The device placement location was unspecified.On (b)(6) 2019, 31 days after the device was placed, the device was removed by the physician.It is reported that when the physician proceeded to remove the device, the wound had closed.The physician had to make a new incision to access and remove the balloon.It is reported that the balloon was found deflated and having migrated into the cyst cavity.The patient's outcome post procedure is unknown at this time.Additional information has been requested regarding the original placement location of the device, as well as other pertinent details regarding the patient and the event.At the time of this report, no additional information has been provided.Precaution listed on the instructions for use (ifu): epithelization time may vary depending on each patient.The word catheter-silicone bartholin gland balloon is not intended to be left indwelling for periods of time greater than twenty-eight (28) days.Instructions for use include: clean area surrounding bartholin gland with appropriate antiseptic solution.Using enclosed scalpel, make an incision in the outer wall of the cyst, preferably inside the hymenal ring, to break up loculations.Once the abscess has been drained, insert deflated silicone catheter through the incision and into the cystic body.Using the enclosed syringe, carefully inflate the silicone catheter with sterile saline until the balloon is sufficiently retained in the cyst, not exceeding maximum inflation volume of the device (3ml).Once inflated, remove the syringe and needle, leaving the saline-inflated word catheter within the cystic mass.Tuck free end of the catheter up into the vagina.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Event Description

Additional information received.The patient was a 38 year old female weighing 50kg with no prior medical history.The syringe used to inflate the device was the syringe included in the kit, and the balloon was inflated to 2.5 ml.It was clarified that the device was originally placed in the cyst.The patient required a new surgical incision under local anesthesia to remove the device.The patient is reported to be doing well post-procedure.

Manufacturer Narrative

Additional information: investigation ¿ evaluation.A visual inspection, dimensional verification and functional testing of the returned device was conducted.A document based investigation was also performed including a review of complaint history, the device history record, drawings, instructions for use, manufacturing instructions, quality control data, and specifications.One device returned for investigation.The length of the returned device measures 5.5 cm and the outside diameter measures.184¿.Functional testing noted the balloon inflated and deflated fine.There are no leaks in the balloon.The balloon is intact.There is a small slow leak in the catheter shaft.A review of the device history record for lot number 9056658 showed no non-conformances related to the reported failure mode.A review of complaint history revealed no other complaint associated with lot number 9056658.The instructions for use (ifu) provides the following information to the user related to the reported failure mode: word catheter-silicone bartholin gland balloon set: clean area surrounding bartholin gland with appropriate antiseptic solution.Using enclosed scalpel, make an incision in the outer wall of the cyst, preferably inside the hymenal ring.Once the abscess has drained, insert the deflated silicone catheter through the incision and into the cystic body.Using the enclosed syringe, carefully inflate the silicone catheter with sterile saline until the balloon is sufficiently retrained in the cyst, not exceeding maximum inflation volume of the device (3ml).Once inflated, remove the syringe and needle, leaving the saline-inflated word catheter balloon within the cystic mass.Tuck free end of the catheter up into the vagina.After epithelization of a new orifice is accomplished, carefully deflate the balloon using a sterile syringe with needle tip, and remove the catheter.Precautions: epithelization time may vary depending on each patient.The word catheter-sillicone bartholin gland balloon is not intended to be left indwelling for periods of time greater then twenty-eight (28) days.There is no indication that a design process or related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.A functional test performed on the returned j-bgc-015055 found a slow leak in the balloon catheter.A leak would cause the balloon to deflate over time, and allow the catheter to migrate to a new position.These catheters are leak tested prior to distribution.The cause of the leak could not be determined in this instance.The leak may have occurred due to misalignment of the syringe needle poking a hole in the catheter during initial inflation of the balloon.The device was in place for 31 days which is longer than the recommended 28 days as stated in the instructions for use (ifu).This likely led to the wound closure and the need for an additional incision to remove the device.The assigned likely cause category for this failure mode is - cause traced to user.Per the quality engineering risk assessment, no further action is warranted.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

There has been no new event information received since the last report was submitted.

• Brand Name: WORD CATHETER SILICONE BARTHOLIN GLAND BALLOON
• Type of Device: KNA INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8284530
• MDR Text Key: 134315301
• Report Number: 1820334-2019-00206
• Device Sequence Number: 1
• Product Code: KNA
• UDI-Device Identifier: 00827002554429
• UDI-Public: (01)00827002554429(17)210731(10)9056658
• Combination Product (y/n): N
• PMA/PMN Number: K102141
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: G55442
• Device Catalogue Number: J-BGC-015055
• Device Lot Number: 9056658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Date Manufacturer Received: 03/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR
• Patient Weight: 50