MAUDE Adverse Event Report: COOK INC COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER; MPR STENT, BLADDER, FETAL

Model Number N/A

Device Problem Bent (1059)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/18/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Event Description

It was reported by the sales rep that a patient underwent a procedure to manage decompression.The two attending physicians decided to use the harrison fetal bladder stent set for a fetal chest (lung for pleural effusion) procedure which is contraindicated and against instructions for use.The sales rep, was unable to advise them nor was able to comment on the failure of the device in this capacity and stressed this was not indicated for that use.The procedure was unsuccessful, the product positioner was bent during surgery and the patient has to return the following week for another operation.There were no unintended sections of the device that remained inside of the patients¿ body, nor did the patient experience any adverse effects due to this occurrence.No further information was provided.

Manufacturer Narrative

Investigation - evaluation: a review of complain history, device history record, instructions for use (ifu), manufacturing instructions and quality control of the device was conducted during the investigation.The complaint device was not returned for investigation.There is no indication that a design or process related failure mode contributed to this event.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.Based on the provided information, no conclusion can be drawn hence the root cause is unknown.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.Per the risk assessment no further action is required.

Manufacturer Narrative

Investigation - evaluation: a review of the instruction for use (ifu), quality control and specification of the device was conducted during the investigation.The complaint device was not returned for investigation.There is no indication that a design or process related failure mode contributed to this event.Review of the ifu and quality documentation did not observe any specific issues with current controls that may have contributed to this incident.Review of device history and complaint history could not be conducted since the lot number was not provided.The harrison fetal bladder stent set (hfbs) is designed and intended for use in a fetal bladder organ with the condition indicated.However, the customer used the product in a fetal chest (lung for pleural effusion) which is contraindicated and against the ifu.Based on the provided information the root cause is product use or handling related because the surgeon did not follow instructions for use of the device.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.Per the risk assessment no further action is required.

• Brand Name: COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER
• Type of Device: MPR STENT, BLADDER, FETAL
• 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: 6340656
• MDR Text Key: 67722060
• Report Number: 1820334-2017-00203
• Device Sequence Number: 1
• Product Code: MPR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: J-CHSG-703001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/12/2017
• Date Device Manufactured: 11/29/2016
• 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
• Patient Outcome(s): Other