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

Model Number	G17870
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/06/2019
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 an unknown procedure using a cook silicone balloon hysterosalpingography injection catheter, the device was placed properly, inflated with 1.3ml of liquid and the balloon ruptured.The procedure was completed by using another new device.No adverse effects have been reported due to the alleged malfunction.
Event or Problem Description
No new patient or event information has been provided since the last report.
Additional Manufacturer Narrative
Ec method code desc - 5: communication/interviews (4011).Investigation ¿ evaluation.A visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, the device history record, instructions for use, specifications, and quality control data.The complainant returned one open package containing a cook silicone balloon hysterosalpingography injection catheter for investigation.Reported lot number confirmed.Visual examination confirmed catheter received bowed and in used condition.Magnification of the catheter tip confirmed the balloon is ruptured exposing the notch port in the inflation line.Balloon displays a tear like seam in a horizontal direction at the top of the burst seam.A review of the device history record revealed no non-conformances related to the reported failure.A review of complaints records found no other complaints associated with this lot.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.Cook also reviewed product labeling.The product ifu provides the following information to the user related to the reported failure mode: precautions "do not overinflate.Using excessive pressure to inflate the balloon on this device can cause the balloon to rupture." "refer to product label of the inflation check valve on the balloon device for appropriate balloon volume." how supplied "upon removal from the package, inspect the product to ensure no damage has occurred." a review of relevant manufacturing documents was conducted.There is no indication that a design related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.The complaint was confirmed based on customer testimony and evaluation of the returned device.Based on the available information, the most likely cause of the event was concluded to be unintended use error.Per the quality engineering risk assessment, no additional risk mitigating activity is required.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
• Common Device Name: HES INSUFFLATOR-CARBON DIOXIDE, URETOTUBAL (AND ACCESSORIES)
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9497014
• Report Number: 1820334-2019-03155
• Device Sequence Number: 19333343
• Product Code: HES
• UDI-Device Identifier: 00827002178700
• UDI-Public: (01)00827002178700(17)220809(10)9941141
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K891290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2020

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: 08/09/2022
• Device Model Number: G17870
• Device Catalogue Number: J-CHSG-703000
• Device Lot Number: 9941141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 12/19/2019
• Supplement Report FDA Received Date: 01/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Weight: 49