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

Catalog Number J-CHSG-503000

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(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, the cook silicone balloon hysterosalpingography injection catheter was working well during a hysterosalpingogram procedure.Once the diagnosis on patient was completed, the doctor tried to deflate the balloon prior to removal, but discovered that the balloon would not deflate.They managed to partially deflate the balloon with a small volume retrieved by the syringe, allowing them to remove the device from the patient.Additional information has been requested regarding the patient.At the time of this report, no further information has been provided.No adverse events have been reported as a result of the alleged malfunction.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: investigation ¿ evaluation.Visual examination and functional testing of the returned product was performed.Additionally, a review of complaint history, the device history record, drawings, instructions for use, manufacturing instructions, quality control data, specifications, and trends was conducted.One cook silicone balloon hysterosalpingography injection catheter was returned for investigation.The returned packaging confirms the product lot number is 7585262.Visual examination noted there is a kink in the catheter located 7.5 cm from the distal tip.The catheter is bent at the manifold.Functional testing of the device was performed.The balloon inflated and deflated as intended.The device history record was reviewed; there were no non-conformances related to the reported failure mode.A review of complaints revealed this complaint to be 1 of 3 complaints associated with the complaint lot number 7585262 for the same complaint issue.Two additional complaints have been created as this customer has indicated they have experienced this same issue on 2 other occasions when using this same complaint device lot.A review of relevant manufacturing documents was conducted.The device is inspected visually and functionally for leaking and inflation during manufacturing and no notable gaps in production or processing controls were noted.To conclude, visual examination noted a kink and bend in the catheter.A functional test found the balloon inflated and deflated as intended.The results of the investigation differ from the customer¿s problem statement as the balloon inflated and deflated as intended.The cause of the customer¿s difficulty cannot be determined.Measures have been initiated to address this failure mode.Cook medical has notified the appropriate personnel and 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

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

• 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: 7942459
• MDR Text Key: 123205644
• Report Number: 1820334-2018-03023
• Device Sequence Number: 1
• Product Code: HES
• UDI-Device Identifier: 00827002171473
• UDI-Public: (01)00827002171473(17)200112(10)7585262
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2020
• Device Catalogue Number: J-CHSG-503000
• Device Lot Number: 7585262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2018
• Date Manufacturer Received: 11/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SYRINGE AND CONTRAST MEDIUM