MAUDE Adverse Event Report: COOK INC COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER; LKF CANNULA, MANIPULATOR/INJECTOR, UTERINE

Model Number	G17870
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) number- k180291.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, a cook silicone balloon hysterosalpingography injection catheter ruptured when inflated with 1.3ml saline.The device was not tested prior to patient contact.The procedure was completed with a new device.No adverse effects have been reported as a result of this occurrence.
Additional Manufacturer Narrative
Event summary: as reported, a cook silicone balloon hysterosalpingography injection catheter ruptured when inflated with 1.3ml saline.The device was not tested prior to patient contact.The procedure was completed with a new device.No adverse effects have been reported as a result of this occurrence.Investigation - evaluation: reviews of the complaint history, device history record, instructions for use, quality control procedures and visual inspections were conducted during the investigation.One silicone balloon hysterosalpingography injection catheter was returned for investigation.Visual examination of the returned device confirmed that the balloon was ruptured.A document-based investigation evaluation was performed.No related nonconformances were recorded, and there have been no other lot-related complaints received.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 were discovered during reviews of the device manufacturing instructions or quality control procedures.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The instructions for use provided with the device state the following: ¿how supplied: upon removal from the package, inspect the product to ensure no damage has occurred.¿ based on the available information, cook has concluded that a definitive cause of the event could not be determined from the available information.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: COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER
• Common Device Name: LKF CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11782635
• Report Number: 1820334-2021-01296
• Device Sequence Number: 13664871
• Product Code: LKF
• UDI-Device Identifier: 00827002178700
• UDI-Public: (01)00827002178700(17)230422(10)13150250
• Combination Product (Y/N): N
• 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): 07/16/2021

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: 04/22/2023
• Device Model Number: G17870
• Device Catalogue Number: J-CHSG-703000
• Device Lot Number: 13150250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2021
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 07/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Weight: 48