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

Model Number	G19891
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	06/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reporter name and address: postal code: (b)(6).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, a cook cervical ripening balloon w/stylet was used off label for a contraindication in our instructions for use (ifu).The device was used on a vaginal birth after caesarean section (cvbac) patient and caused uterine rupture.The patient required uterine repair.No details regarding the uterine repair was provided.No additional patient consequences were reported.Additional information has been requested regarding the patient and the event.At the time of this report, no further information has been provided.
Event or Problem Description
No new patient or event information since the last report was submitted.
Additional Manufacturer Narrative
Event summary: as reported, a cook cervical ripening balloon w/stylet was used off label for a contraindication in our instructions for use (ifu).The device was used on a vaginal birth after caesarean section (cvbac) patient and caused uterine rupture.The patient required uterine repair.No details regarding the uterine repair was provided.No additional patient consequences were reported.Additional information has been requested regarding the patient and the event.At the time of this report, no further information has been provided.Investigation - evaluation: a document-based investigation was performed including a review of complaint history, device history record, quality control data, and the instructions for use (ifu).The complaint device was not returned to cook for investigation.Cook has not received a complaint for a similar product and a similar failure mode in which the complaint product was returned for physical examination.A review of the device history record found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other related complaints from the lot have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows no other complaints associated with the complaint device lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: contraindications: "prior hysterotomy, classic uterine incision, myomectomy or any other full-thickness uterine incision" potential adverse events: "uterine rupture" a clinical assessment was conducted and concluded: based on the information provided for this clinical assessment, the most probable cause of this event is related to user/procedural issues related to patient factors/history.With the partial information available at this time, specifications regarding additional patient factors are limited.Based on the information provided, the event can likely be traced to the off-label use of the device for a contraindication in our instructions for use (ifu).Based on the available information, it was concluded that the cause of the event was traced to contraindicated use of the device.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: COOK CERVICAL RIPENING BALLOON W/STYLET
• Common Device Name: PFJ, DILATOR, CERVICAL, HYGROSCOPIC-IAMINARIA
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 12141912
• Report Number: 1820334-2021-01725
• Device Sequence Number: 4154819
• Product Code: PFJ
• UDI-Device Identifier: 00827002198913
• UDI-Public: (01)00827002198913(17)231118(10)13565324
• Combination Product (Y/N): N
• PMA/510(K) Number: K131206
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/18/2023
• Device Model Number: G19891
• Device Catalogue Number: J-CRBS-184000
• Device Lot Number: 13565324
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/17/2021
• Supplement Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 07/09/2021
• Supplement Report FDA Received Date: 09/24/2021
• 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: Required Intervention