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 Consequences Or Impact To Patient (2199)
Date of Event	06/24/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).510(k): k131206.Event is still under investigation at this time.
Event or Problem Description
Vagina balloon was good when injected with 20ml of saline, but after continuing to inject 10ml of saline the balloon ruptured and leaked.Updated information from the rep 28june2016: the balloon ruptured circumferentially while within the patient.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 complaint history, drawings, device history record, instructions for use (ifu) was conducted during the investigation.A physical investigation was done on the returned complaint device.A visual examination noted the balloon to have a circumference split.It is feasible to suggest the balloon was over inflated initially.The device is shipped with instructions for use (ifu), which states the proper warnings, precautions, and instructions for use.A review of production and quality documentation did not observe any specific issues with current controls that may have contributed to this incident.Based on the information provided, the actual root cause is unknown and so no conclusion can be drawn.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® 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: 5802595
• Report Number: 1820334-2016-00739
• Device Sequence Number: 16148867
• Product Code: PFJ
• UDI-Device Identifier: 00827002481497
• UDI-Public: (01)00827002481497(17)180417(10)5813666
• 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): 06/27/2016

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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/24/2016
• Device Age: 14 MO
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/27/2016
• Supplement Date Received by Manufacturer: 06/22/2017
• Initial Report FDA Received Date: 07/19/2016
• 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: 71