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

Model Number N/A

Device Problems Inflation Problem (1310); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/14/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

It was reported that prior to performing hysterosalpingogram (hsg), the physician tested a cook silicone balloon hysterosalpingography injection catheter and found that the balloon did not inflate completely.Only the half side of the balloon was seen inflated.It is unknown if the physician completed the intended procedure.No unintended section of the device remained inside the patient's body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Additional information was requested regarding this occurrence; however it is not available at this time.

Manufacturer Narrative

Additional information: device available for evaluation.Investigation ¿ evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), specifications, and visual inspection / functional testing of the returned device was conducted during the investigation.Three opened and fifteen unopened cook silicone balloon hysterosalpingography injection catheters were returned for investigation.The three opened devices were inspected.The black plunger measures 3mm protruding, prior to inflation.Functional testing was performed.The three balloons were all inflated, but a visual examination noted two of the balloons were asymmetrical.After deflation, the plunger still measured 3mm protruding.One of the open devices was accidentally over inflated during the investigation progress.The fifteen unopened devices were inspected.The black plunger measured 3mm protruding, prior to inflation.A functional test was performed.All 15 balloons inflated fine, but seven were found to be asymmetrical.It was noted that more force was needed when applying pressure to the plunger to deflate the balloons; however, all 15 balloons deflated.The black plungers measured 3 mm protruding after deflation.The device history record was reviewed and found one non-conformance issue noted during manufacturing for eight units with damaged fittings.A review of complaint history for this product/lot number combination revealed this is one of two complaints associated with complaint lot number 7812398.The other is complaint report was for the issue of the balloon could not be deflated.Based on the information provided, the actual root cause is unknown and no conclusion can be drawn.Measures have been initiated to address this failure mode.Monitoring will continue to be performed for similar complaints.

Event Description

It was reported that prior to performing hysterosalpingogram (hsg), the physician tested a cook silicone balloon hysterosalpingography injection catheter and found that the balloon did not inflate completely.Only the half side of the balloon was seen inflated.Upon partial inflation of the balloon, the user could not deflate it.It is unknown if the physician completed the intended procedure.No unintended section of the device remained inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• 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
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6681120
• MDR Text Key: 78982903
• Report Number: 1820334-2017-01593
• Device Sequence Number: 1
• Product Code: HES
• UDI-Device Identifier: 00827002171473
• UDI-Public: (01)00827002171473(17)200407(10)7812398
• Combination Product (y/n): N
• Reporter Country Code: ES
• PMA/PMN Number: K891290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: J-CHSG-503000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1