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 Deflation Problem (1149); 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, the physician tested a cook silicone balloon hysterosalpingography injection catheter.It was further reported that the balloon inflated completely, however it failed to deflate.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

Investigation ¿ evaluation: as anticipated, the cook silicone balloon hysterosalpingography injection catheter was not returned for evaluation.No photos have been provided.Without the complaint device, a physical investigation was not able to be completed.There is no indication that a design or process related failure mode contributed to this event.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.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 did not get inflated completely.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.Per the quality engineering risk assessment, no further action is required.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
• 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: 6681755
• MDR Text Key: 78985893
• Report Number: 1820334-2017-01594
• 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: 09/27/2017

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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/27/2017
• 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