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	02/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 on (b)(6) 2019, the cook silicone balloon hysterosalpingography injection catheter balloon was inflated to test it before usage in an hysterosalpingography (hsg) procedure but the balloon could not be deflated.After half an hour, the balloon deflated on its own.A different catheter was used to treat the patient that did deflate properly.There was no harm to the patient.Additional information provided on (b)(6) 2019.As reported the balloon was inflated to circa 3 ml with air using the provided syringe with no difficulty, but it would not deflate.We did not use this catheter; no patient contact.There was no leakage observed.
Additional Manufacturer Narrative
Investigation ¿ evaluation.A visual inspection and functional testing of the returned device was conducted.A document based investigation was also performed including a review of complaint history, the device history record, manufacturing instructions, quality control data, and trends.One device was returned for investigation.The returned packaging confirms lot number 9279409.The device was returned with a 5-cc syringe attached to the hub.Functional testing notes the balloon inflated without incident.Pressure was needed to depress the plunger to deflate the balloon.A review of the device history record for lot number 9279409 showed no non-conformances that would have caused or contributed to the reported failure mode.A review of complaint history revealed no other complaints associated with lot 9279409.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.The complaint was confirmed based on evaluation of the returned device.Pressure was needed to depress the plunger to deflate the balloon.An investigation conclusion could not be established.Per the quality engineering risk assessment, no further action is warranted.The appropriate internal personnel have been notified and we will continue to monitor 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 or Problem Description
There has been no new event information received since the last report was submitted.

• 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: 8387258
• Report Number: 1820334-2019-00532
• Device Sequence Number: 16240675
• Product Code: HES
• UDI-Device Identifier: 00827002174719
• UDI-Public: (01)00827002174719(17)211101(10)9279409
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2019

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: 11/01/2021
• Device Model Number: G17471
• Device Catalogue Number: J-CHSG-703001
• Device Lot Number: 9279409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Initial Date Received by Manufacturer: 02/18/2019
• Supplement Date Received by Manufacturer: 03/22/2019
• Initial Report FDA Received Date: 03/04/2019
• Supplement Report FDA Received Date: 04/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1