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	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported, during an unknown procedure in which a cook silicone balloon hysterosalpingography injection catheter was used, that prior to patient contact, when filling the balloon it ruptured.It is unknown how the procedure was completed.It was reported that the patient did not experience any adverse effects due to this occurrence.Additional information has been requested regarding the patient and the event.At the time of this report, no further information has been provided.
Event or Problem Description
No new patient or event information since the last report was submitted on 22oct2019.
Additional Manufacturer Narrative
H6: ec method code desc - 5: communication/interview (4111).Investigation/evaluation: a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, the instructions for use, specifications, and quality control data.One device was returned for investigation.The returned packaging confirms the reported complaint device lot number.Visual examination confirmed the catheter was received in unused condition.Several areas of damage were noted starting at the distal tip and continued to the lumen junction fitting.The damage was likely caused by the return shipping.The balloon was ruptured and had a curvature in each end of the rupture.Balloons are leak tested using air during manufacturing and again during inspection processes.A review of the device history record found 3 non-conformances related to the reported failure mode.Cook was not able to determine if the leakage non-conformances were related to the reported incident.The device history record (dhr) for subassembly lot records no non-conformances.A review of complaint history records shows no other complaints associated with the complaint device lot.Because 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.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: warning: always inflate the balloon with sterile liquid.Never inflate with air, carbon dioxide or any other gas.Precautions: do not over inflate.Using excessive pressure to inflate the balloon on this device can cause the balloon to rupture.Refer to product label or the inflation check valve on the balloon device for appropriate balloon volume.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Cook has concluded that unintended user error contributed to this incident.The complaint was confirmed based on customer testimony and evaluation of the returned device.Most probable cause over inflation causing balloon to burst.Per the quality engineering risk assessment, no further action is warranted.Cook medical 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: 9218495
• Report Number: 1820334-2019-02669
• Device Sequence Number: 16683882
• Product Code: HES
• UDI-Device Identifier: 00827002171473
• UDI-Public: (01)00827002171473(17)220320(10)9607640
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 11/21/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/20/2022
• Device Model Number: G17147
• Device Catalogue Number: J-CHSG-503000
• Device Lot Number: 9607640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2019
• Initial Date Received by Manufacturer: 10/17/2019
• Supplement Date Received by Manufacturer: 11/21/2019
• Initial Report FDA Received Date: 10/22/2019
• Supplement Report FDA Received Date: 11/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1