MAUDE Adverse Event Report: COOK INC COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS; OQY INTRAUTERINE BALLOON

Model Number G24237

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 04/22/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).Pma/510k #: k170622.(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 is reported during treatment using a cook bakri postpartum balloon with rapid instillation components, the one-way valve on the tube separated in the uterus when inserting via uterotomy.The separated component accidentally remained in the cavum, and the patient required a hysteroscopy and dilation and curettage (d&c) to remove the retained device component.No additional consequences to the patient have been reported as a result of this occurrence.Additional details regarding the patient and event have been requested.At this time, no additional information has been provided.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: corrected information: investigation ¿ evaluation.A visual inspection and functional testing of the returned device could not be conducted since the complaint device was not returned.A document based investigation was performed including a review of complaint history, the device history record, quality control data, and instructions for use (ifu).A device history record (dhr) review for this lot shows no non-conformances.A review of complaint history revealed no other complaints associated with the complaint device lot number.A review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.Because there are no non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.The ifu for this device provides the following information to the user related to the reported failure mode: instructions "transabdominal placement, post-cesarean section" determine uterine volume by direct examination." from above, via access of the cesarean incision, pass the tamponade balloon, inflation port first, through the uterus and cervix." "note: remove and stopcock to aid in placement and reattach prior to filling balloon." the complaint was confirmed based on complainant testimony.The most probable cause for this incident was determined to be the user's failure to follow the ifu.Measures have been initiated to address this failure mode.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

Additional information provided: the device segment remained in the uterus for one month.Dilation of the cervix to hega 15 was required to retrieve the retained one-way valve of the device because it was stuck in the cervix.

• Brand Name: COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS
• Type of Device: OQY INTRAUTERINE BALLOON
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8697445
• MDR Text Key: 148003574
• Report Number: 1820334-2019-01396
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002242378
• UDI-Public: (01)10827002242378(17)220403(10)9639843
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/03/2022
• Device Model Number: G24237
• Device Catalogue Number: J-SOSR-100500
• Device Lot Number: 9639843
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other