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	06/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Pma/510(k): k131206.Event is still under investigation at this time.
Event or Problem Description
The initial information provided stated that the balloon was broken and leaking when injecting 20ml saline.Upon receipt of the product, it was noted the balloon had ruptured in a circumferential direction.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
One complaint device was returned for investigation.The check in photos show a split in the balloon.A search of the manufacturer's database identified this complaint to be one of two complaints associated with lot 5813666.

• 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: 5802373
• Report Number: 1820334-2016-00731
• Device Sequence Number: 19005961
• Product Code: PFJ
• UDI-Device Identifier: 00827002481497
• UDI-Public: (01)00827002481497(17)180417(10)5813666
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K131206
• 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): 06/28/2017

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: 06/22/2016
• Device Age: 14 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/27/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/18/2016
• Supplement Report FDA Received Date: 06/28/2017
• 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
• Patient Age: 27 YR
• Patient Weight: 68