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

Model Number	G17471
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/02/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It is reported during a hysterosalpingography procedure using a cook silicone balloon hysterosalpingography injection catheter, the physician had difficulty with deflating the balloon.The patient did not experience any adverse effects or require any additional procedures as a result of this occurrence.No section of the device remained inside the patient's body.Additional details regarding the patient and event have been requested.At this time, no additional information has been provided.
Additional Manufacturer Narrative
Event summary: it is reported during a hysterosalpingography procedure using a cook silicone balloon hysterosalpingography injection catheter, the physician had difficulty with deflating the balloon.The patient did not experience any adverse effects or require any additional procedures as a result of this occurrence.No section of the device remained inside the patient's body.Investigation - evaluation.Reviews of the complaint history, device history record, instructions for use (ifu), and quality control procedures of the device were conducted during the investigation.The device was not returned for investigation.No physical examination could thus be conducted.A document-based investigation evaluation was performed.No related non-conformances were recorded, and no additional lot-related complaints were received.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence that nonconforming product exists in house or in field.There were no identified gaps in the quality control 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 state, ¿upon removal from the package, inspect the product to ensure no damage has occurred." based on the information available, investigation has concluded that a definitive cause for this event could not be determined.We will continue our monitoring of similar complaints.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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 10251868
• Report Number: 1820334-2020-01280
• Device Sequence Number: 18961497
• Product Code: HES
• UDI-Device Identifier: 00827002174719
• UDI-Public: (01)00827002174719(17)211030(10)9272914
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K891290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2020

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: 10/30/2021
• Device Model Number: G17471
• Device Catalogue Number: J-CHSG-703001
• Device Lot Number: 9272914
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/02/2020
• Supplement Date Received by Manufacturer: 08/14/2020
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 08/28/2020
• 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: SPECULUM,SALINE,AIR.; SPECULUM,SALINE,AIR.