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

Model Number G17147

Device Problem Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/26/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 an unspecified procedure using a cook silicone balloon hysterosalpingography injection catheter, the balloon was burst and would not inflate.The procedure was completed with another device.The patient did not experience any adverse effects as a result of this occurrence.Additional details have been requested regarding the patient and event.At this time, no additional information has been provided.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Corrected information: b5 additional information: b5 this report includes information known at this time.A follow up report will be submitted should additional relevant information become available.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

Information that was inadvertently not reported on the initial mdr: it was reported, the catheter was placed, and upon inflation, fluid was observed leaking from the other port.The catheter removed then repositioned and inflated again only to see the same issue.Additional information was received (b)(6) 2020: the procedure being performed was a hysterosalpingo-contrast sonography (hycosy).The device was tested prior to patient contact and there was no mention of an issue with the device.Once the catheter was inserted past the cervix when instilling the saline into the balloon the balloon did not inflate.

Manufacturer Narrative

H6: ec method code desc - 5: communication/interviews (4111).Event description: an incident was reported on (b)(6) 2020 involving a cook silicone balloon hysterosalpingography injection catheter.As reported, the complaint balloon would not fill properly during use.The procedure being performed was hysterosalpingo-contrast sonography (hycosy).The device was tested prior to patient contact.Once the catheter was inserted past the cervix when instilling the saline into the balloon the balloon was burst and did not inflate.Another device was used to successfully complete the procedure.No adverse events were reported.Investigation - evaluation: a document-based investigation was performed including a review of complaint history, device history record, quality control data, and the instructions for use (ifu).The complaint device was not returned; therefore, no physical examinations could be 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.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 related complaints from the lot have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows no other complaints associated with the complaint device lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: how supplied: "upon removal from the package, inspect the product to ensure no damage has occurred." the complainant did not return the complaint device to cook for investigation.It is possible that unintended user error could have contributed to the incident.However, a definitive cause of the events could not be determined from the available information.Per the quality engineering risk assessment, no further action is warranted.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 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: 10110936
• MDR Text Key: 198140967
• Report Number: 1820334-2020-01048
• Device Sequence Number: 1
• Product Code: HES
• UDI-Device Identifier: 00827002171473
• UDI-Public: (01)00827002171473(17)230312(10)13047357
• 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,Followup
• Report Date: 07/07/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2023
• Device Model Number: G17147
• Device Catalogue Number: J-CHSG-503000
• Device Lot Number: 13047357
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/26/2020
• Initial Date FDA Received: 06/02/2020
• Supplement Dates Manufacturer Received: 06/09/2020; 06/24/2020
• Supplement Dates FDA Received: 06/23/2020; 07/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1