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

Model Number G17870

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported that after a hysterosalpingography was completed, the health care provider attempted to remove the cook silicone balloon hysterosalpingography injection catheter that was used during the procedure.There were issues removing the catheter from the uterus due to the balloon not deflating.They were eventually able to deflate the balloon.The initial reporter stated that the event occurred on four separate occasions.(patient reference identifier # (b)(6)) no adverse event was reported due to this malfunction.

Event Description

Update 21aug2019: the procedure being performed was a sonoisterosalpingography in vagina, cervix, and uterus.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

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 5 other complaints associated with the complaint device lot, all reported by the same customer and all involved issue with balloon deflation once the procedure was over.Due to the individual nature of the manufacturing and inspection process for the devices in the lots, it is unlikely that these events are an indication of an issue with the entire 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 for investigation.At the time of the complaint investigation, all products in the lot have been distributed to customers, so no representative product is available from the lot for evaluation.Cook has concluded a definitive conclusion could not be determined.Per the quality engineering risk assessment, no further action is warranted.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.

• 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: 8883918
• MDR Text Key: 154421978
• Report Number: 1820334-2019-01988
• Device Sequence Number: 1
• Product Code: HES
• UDI-Device Identifier: 00827002178700
• UDI-Public: (01)00827002178700(17)210126(10)8539787
• Combination Product (y/n): N
• PMA/PMN Number: K891290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/26/2021
• Device Model Number: G17870
• Device Catalogue Number: J-CHSG-703000
• Device Lot Number: 8539787
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1