MAUDE Adverse Event Report: COOK INC COOK® CERVICAL RIPENING BALLOON; PFJ, DILATOR, CERVICAL, HYGROSCOPIC-IAMINARIA

Model Number	N/A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/06/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event is currently under investigation.
Event or Problem Description
During a labor induction procedure, the uterus balloon burst at 80 ml when injecting saline.The balloon reportedly burst in a circumferential direction.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation : a review of the drawing, quality control and visual inspection, device history record, documentation, instructions for use (ifu), manufacturing instructions, and specifications of the returned device was conducted during the investigation.A physical investigation was done on the returned complaint device.A visual examination shows the uterus balloon has longitudinally split.The device is shipped with instructions for use (ifu) which states the proper warnings, precautions, and instructions for use.A document based investigation evaluation was also 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.It should be noted there were no other reported complaints for this lot number.Based on the information provided, the actual root cause is unknown and so no conclusion can be drawn.We will notify the appropriate personnel and 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® CERVICAL RIPENING BALLOON
• Common Device Name: PFJ, DILATOR, CERVICAL, HYGROSCOPIC-IAMINARIA
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5945077
• Report Number: 1820334-2016-00909
• Device Sequence Number: 636264
• Product Code: PFJ
• UDI-Device Identifier: 00827002481497
• UDI-Public: (01)00827002481497(17)181106(10)6360165
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2016

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: J-CRB-184000
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/16/2016
• Supplement Date Received by Manufacturer: 06/22/2017
• Initial Report FDA Received Date: 09/13/2016
• Supplement Report FDA Received Date: 07/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Weight: 64