MAUDE Adverse Event Report: COOK INC BALLOON UTERINE STENT; KNA INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC

Model Number	G17562
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, the packaging of a balloon uterine stent was found damaged before the device could be used.A photo provided by the user shows a pinhole in the device packaging.The procedure was completed using a new device.No adverse effect to the patient has been reported as a result of this occurrence.
Additional Manufacturer Narrative
Event summary: as reported, the packaging of a balloon uterine stent was found damaged before the device could be used.A photo provided by the user shows a pinhole in the device packaging.The procedure was completed using a new device.No adverse effect to the patient has been reported as a result of this occurrence.Investigation - evaluation: reviews of the complaint history, device history record, instructions for use, and quality control procedures of the device were conducted during the investigation.No device was returned for investigation.Photos provided by the user appear to show a pinhole in the device packaging.A document-based investigation evaluation was performed.One relevant nonconformance was recorded; all affected product was scrapped.There have been no other reported complaints for this lot number.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.A review of relevant manufacturing documents was conducted.No gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.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.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is provided with instructions for use which state, "sterile if the package is unopened or damaged.Do not use if package is broken." based on the available information, cook has concluded that transport and/or storage of the complaint device contributed to the incident.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: BALLOON UTERINE STENT
• Common Device Name: KNA INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 12468448
• Report Number: 1820334-2021-02152
• Device Sequence Number: 19676923
• Product Code: KNA
• UDI-Device Identifier: 00827002175624
• UDI-Public: (01)00827002175624(17)220912(10)10007396
• Combination Product (Y/N): N
• PMA/510(K) Number: K952527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/12/2022
• Device Model Number: G17562
• Device Catalogue Number: J-BUS-404000
• Device Lot Number: 10007396
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/16/2021
• Supplement Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 09/14/2021
• Supplement Report FDA Received Date: 10/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1