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

Catalog Number	J-CHSG-503001
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Event is currently under investigation.A follow up report will be send upon conclusion.
Event or Problem Description
It was reported that during treatment, once the balloon was inflated with saline solution, the balloon would not deflate.Once the balloon is inflated it does not return to its normal shape.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation: one open and nine unopened cook silicone balloon hysterosalpingography injection catheters were returned for evaluation.The opened device was visually examined and noted that the flare was slightly crooked.The black plunger protruded 3 mm prior to inflation.The balloon was functionally tested.The balloon inflated symmetrically.When deflating the balloon, extra force was needed when applying pressure to the black plunger to the syringe to get it connected so that it could be deflated.The nine unopened balloons were opened and functionally tested.Each balloon was inflated with water.Two (2) balloons inflated asymmetrically and deflated without issue.Seven (7) balloons inflated symmetrically.Three (3) of these deflated fine and the other four (4) observed the syringe was tight and required more force to make connection to the plunger in order to be deflated.A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident.A review of the device history record revealed two non-conformances during the manufacturing process.However, these issues are unrelated and would not have caused or contributed to the reported deflation failure.A review of complaint history for this product/lot number combination revealed there has been one (1) other similar complaint received.Measures have been initiated to address this failure mode.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• 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: 6733699
• Report Number: 1820334-2017-01833
• Device Sequence Number: 1371325
• Product Code: HES
• UDI-Device Identifier: 00827002174726
• UDI-Public: (01)00827002174726(17)200324(10)7776324
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• 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): 08/25/2017

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 Catalogue Number: J-CHSG-503001
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/03/2017
• Supplement Date Received by Manufacturer: 08/24/2017
• Initial Report FDA Received Date: 07/21/2017
• Supplement Report FDA Received Date: 08/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1