MAUDE Adverse Event Report: COOK INC GOLDSTEIN SONOHYSTEROGRAPHY CATHETER; HFF ASPIRATOR, ENDOMETRIAL

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/03/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
Per the mw5062932, reported through the fda voluntary event reporting process, the manufacturer was informed that the ob/gyn personnel inserted a saline infusion sonography catheter into the female patient for ultrasound.The device was removed and patient was sent home.The following day, the patient reported that a piece of white plastic fell out of her vagina.Patient returned to office to report and was very angry that a piece of the catheter was left in her to fall out.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), specifications and trends was conducted during the investigation.The complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.The device is shipped with an instruction for use (ifu) that describes the intended use, specific items are addressed such as: the "catheter is removed upon completion of ultrasound procedure." the instructions for use also state "note: upon removal of catheter, ensure that positioner is still on body of catheter.If still lodged in patient cervix, remove using forceps." based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
Event or Problem Description
Per the mw5062932, reported through the fda voluntary event reporting process, the manufacturer was informed that the ob/gyn personnel inserted a saline infusion sonography catheter into the female patient for ultrasound.The device was removed and patient was sent home.The following day, the patient reported that a piece of white plastic fell out of her vagina.Patient returned to office to report and was very angry that a piece of the catheter was left in her to fall out.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

• Brand Name: GOLDSTEIN SONOHYSTEROGRAPHY CATHETER
• Common Device Name: HFF ASPIRATOR, ENDOMETRIAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5843993
• Report Number: 1820334-2016-00693
• Device Sequence Number: 16263920
• Product Code: HFF
• UDI-Device Identifier: 00827002190122
• UDI-Public: (01)00827002190122(17)180629(10)5996975
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K060908
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2016

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: J-GSHC-542600-SV
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/03/2016
• Supplement Report FDA Received Date: 12/23/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other