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

Model Number G17471

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/02/2020

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 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.

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 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
• Type of Device: HES INSUFFLATOR-CARBON DIOXIDE, URETOTUBAL (AND ACCESSORIES)
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10251868
• MDR Text Key: 198146895
• Report Number: 1820334-2020-01280
• Device Sequence Number: 1
• Product Code: HES
• UDI-Device Identifier: 00827002174719
• UDI-Public: (01)00827002174719(17)211030(10)9272914
• 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: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SPECULUM,SALINE,AIR.; SPECULUM,SALINE,AIR.