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 Date 03/28/2019

Event Type  malfunction  

Manufacturer Narrative

This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported during a hysterosalpingogram (hsg) procedure this week 2 cook silicone balloon hysterosalpingography injection catheters once inflated did not deflate when required.Fortunately, the radiologist tested these catheters before patient use as this would have caused cervical shock if trying to remove with an inflated balloon.The patient's examinations had to be abandoned as we did not have an alternative.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.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

Additional information received on 30apr2019 from the initial reporter.The number of patients involved was 2.The patients ages were approximately 37-40.Unable to provide information about patient's health & history.The procedures went ahead using alternative devices.The patients suffered no adverse effects as the balloon catheters were tested before use on the patients.The 2nd patient event will be reported in mfr.Report # 1820334-2019-01114.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation.The complainant returned one open package and three unopened packages each containing cook silicone balloon hsg catheter for investigation.Lot number of returned items confirms customer report.Visual examination confirmed no visible damage on the balloons.Functional testing performed by inflating balloons with air using a 10ml syringe; each balloon inflated properly.When deflating firm pressure applied to the inflation valve is necessary to deflate; all four balloons deflated properly.A review of the device history record found there were no related non-conformances with this lot.A review of complaint history records revealed 1 other complaint associated with this device lot number.Pr262208 was reported by the same customer for the same failure mode as this complaint.Cook also reviewed product labeling.The product ifu, t_j-chsg_rev0 ¿cook silicone balloon hsg catheter¿ provides the following information to the user related to the reported failure mode: warnings "always inflate the balloon with a sterile liquid.Never inflate with air, carbon dioxide or any other gas." how supplied "upon removal from the package, inspect the product to ensure no damage has occurred." most probable cause of this reported event is not enough pressure used to contact syringe with inflation valve.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Cook has concluded a definitive conclusion could not be determined.The device evaluation found normal performance of the complaint device, therefore the complaint could not be confirmed 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.

Event Description

No new information to report.

• 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: 8520058
• MDR Text Key: 142396167
• Report Number: 1820334-2019-00814
• Device Sequence Number: 1
• Product Code: HES
• UDI-Device Identifier: 00827002178700
• UDI-Public: (01)00827002178700(17)210402(10)8710019
• 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: 06/24/2019

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: 04/02/2021
• Device Model Number: G17870
• Device Catalogue Number: J-CHSG-703000
• Device Lot Number: 8710019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2019
• Initial Date Manufacturer Received: 03/28/2019
• Initial Date FDA Received: 04/16/2019
• Supplement Dates Manufacturer Received: 04/30/2019; 06/04/2019
• Supplement Dates FDA Received: 05/23/2019; 06/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1