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

Model Number	G17147
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
It was reported, during a hysterosonosalpingography procedure using a cook silicone balloon hysterosalpingography injection catheter, the intrauterine catheter did not deflate, despite the reported correct use.Numerous attempts were made.Therefore, the catheter was cut on the external portion, allowed to deflate, and extracted from the uterine cavity.No section of the device remained inside the patient¿s body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Additional information has been requested regarding the patient and event.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Additional information: b5, section c.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 or Problem Description
Additional information provided (b)(6) 2020: the device was inflated with 1ml of normal saline (nacl 0.9%) using the provided syringe.There were no difficulties with inserting or connecting the syringe.The device was not tested prior to use.There was no leakage reported.There was no issue with the packaging, or opening of the package.The patient was not positive for covid-19.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Event summary: it was reported, during a hysterosonographic procedure using a cook silicone balloon hysterosalpingography injection catheter, the intrauterine catheter did not deflate, despite the reported correct use.The device was inflated with 1ml of normal saline (nacl 0.9%) using the provided syringe.Numerous attempts were made.Therefore, the catheter was cut on the external portion, allowed to deflate, and extracted from the uterine cavity.No section of the device remained inside the patient¿s body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation - evaluation.Reviews of the complaint history, device history record, instructions for use, manufacturing instructions, specifications, and quality control procedures and a visual inspection and functional test of the device were conducted during the investigation.One open package containing a cook silicone balloon hysterosalpingography injection catheter was returned for investigation in a used condition.The catheter was received severed into two segments.The catheter was severed 26.5cm from the distal tip.The catheter was kinked in three locations starting from the distal tip 1cm, 4cm, and 18cm.No anomalies were noted on the balloon material.The proximal segment measured 4cm from the y connection; a 1ml bd syringe was attached to the inflation fitting.The inflation valve was noted to function properly.A document-based investigation evaluation was performed.No related non-conformances were recorded, and there have been no other reported complaints for this lot number.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.There were no identified gaps in the device manufacturing instructions, specifications, or quality controls procedures.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is packaged with instructions for use, which caution ¿do not overinflate.Using excessive pressure to inflate the balloon on this device and cause the balloon to rupture.¿ based on the available information, cook has concluded that a definitive cause for the reported event could not be determined.We will continue our monitoring of similar complaints and have 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.

• Brand Name: COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER
• Common Device Name: HES INSUFFLATOR-CARBON DIOXIDE, URETOTUBAL (AND ACCESSORIES)
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10199973
• Report Number: 1820334-2020-01201
• Device Sequence Number: 19093997
• Product Code: HES
• UDI-Device Identifier: 00827002171473
• UDI-Public: (01)00827002171473(17)220724(10)9902126
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K891290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/02/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/24/2022
• Device Model Number: G17147
• Device Catalogue Number: J-CHSG-503000
• Device Lot Number: 9902126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2020
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 07/19/2020; 10/12/2020
• Initial Report FDA Received Date: 06/26/2020
• Supplement Report FDA Received Date: 08/14/2020; 11/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CONTRAST.; CONTRAST