MAUDE Adverse Event Report: COOK INC COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER; HES INSUFFLATOR-CARBON DIOXIDE, URETOTUBAL (AND ACCESSORIES)

Model Number G17147

Device Problem Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Occupation: account manager.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

During an unspecified procedure, four cook silicone balloon hysterosalpingography injection catheter were used.The complainant stated the balloon would inflate, but that when the procedure was finished it would not deflate.No adverse effects to the patient have been reported due to this event.Additional information has been requested and a follow-up report will be submitted when/if the requested information is received.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Investigation - evaluation.Reviews of complaint history, device history record, manufacturing instructions, quality control data, and the instructions for use(ifu) were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.Because there are no related 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 instructions for use (ifu), provides the following information to the user related to the reported failure mode: warnings: "always inflate the balloon with a sterile liquid.Never inflate with air, carbon dioxide or any other gas." how supplied: "upon removal from the package, inspect the product to ensure no damage has occurred." the complainant did not return the complaint device for investigation.At the time of the complaint investigation, all products in the complaint device lot have been distributed to customers, so no representative product is available from the lot for evaluation.A definitive cause could not be determined from the available information.Per the quality engineering risk assessment, the risk analysis for this failure mode was reviewed, and it was determined that no additional risk mitigating activity is required.Cook medical will continue to monitor this device via the complaints database 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

No new patient or event information since last report was sent on (b)(6) 2019.

• Brand Name: COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER
• Type of Device: HES INSUFFLATOR-CARBON DIOXIDE, URETOTUBAL (AND ACCESSORIES)
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9072300
• MDR Text Key: 158709369
• Report Number: 1820334-2019-02339
• Device Sequence Number: 1
• Product Code: HES
• UDI-Device Identifier: 00827002171473
• UDI-Public: (01)00827002171473(17)220517(10)9748946
• Combination Product (y/n): N
• PMA/PMN Number: K891290
• 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: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2022
• Device Model Number: G17147
• Device Catalogue Number: J-CHSG-503000
• Device Lot Number: 9748946
• Date Manufacturer Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1