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

Catalog Number	J-CRB-184000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Unspecified Infection (1930)
Date of Event	08/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, on (b)(6) 2023, a pregnant, female, patient was admitted to the hospital due to term pregnancy (40+1) and high blood pressure (preeclampsia).The patient was examined and found to have an immature cervix with a bishop score of 2.On (b)(6) 2023, the user successfully placed a 'cook cervical ripening balloon'; the patient did not report any discomfort during device placement.On (b)(6) 2023 at 0950, approximately 17 hours after placement, the user removed the device and then artificially ruptured the membranes (arom).Approximately 8 hours later, at 1745, it was noted that the patients fetal monitoring was unfavorable and the doctor suspected intrauterine fetal distress (iufd); the patient was examined and it was determined that an emergency cesarean section was indicated.The patient's temperature was assessed and found to be 38.6 (101.5°f); the patient also appeared cold and chilled.At 2030, the patient successfully delivered the fetus via cesarean section.'cefoperazone' and 'sulbactam' 2g was administered every 8 hours for 3 days post-op; after 3 days of continuous anti-infection treatment, the high fever was resolved.At 4 days post-op, 'meropenem' 1g was administered every 6 hours and an intramuscular infection of 'acetaminophen' was administered for fever reduction.It was reported that there was no obvious failure of the device.The user suspected that the patients pre-existing conditions placed her at a higher risk for a uterine infection.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E3: customer occupation = unknown.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.B5: additional information received 21sep2023 and 25sep2023.Corrections: h6 (annex e, annex g) summary of event: as reported, on 14aug2023, a pregnant, female, patient was admitted to the hospital due to term pregnancy (40+1) and high blood pressure (preeclampsia).The patient was examined and found to have an immature cervix with a bishop score of 2.On (b)(6) 2023, the user successfully placed a 'cook cervical ripening balloon'; the patient did not report any discomfort during device placement.On (b)(6) 2023 at 0950, approximately 17 hours after placement, the user removed the device and then artificially ruptured the membranes (arom).Approximately 8 hours later, at 1745, it was noted that the patients fetal monitoring was unfavorable and the doctor suspected intrauterine fetal distress (iufd); the patient was examined and it was determined that an emergency cesarean section was indicated.The patient's temperature was assessed and found to be 38.6¿ (101.5°f); the patient also appeared cold and chilled.At 2030, the patient successfully delivered the fetus via cesarean section.'cefoperazone' and 'sulbactam' 2g was administered every 8 hours for 3 days post-op; after 3 days of continuous anti-infection treatment, the high fever was resolved.At 4 days post-op, 'meropenem' 1g was administered every 6 hours and an intramuscular infection of 'acetaminophen' was administered for fever reduction.It was reported that there was no obvious failure of the device.The user suspected that the patients pre-existing conditions placed her at a higher risk for a uterine infection.Additional information received 21sep2023 and 25sep2023: the patients blood was cultured in an attempt to determine the cause of the fever; the 'providencia rettgeri' was also cultured.The patients blood culture result was 'negative'.Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control (qc) procedures were conducted during the investigation.A document-based investigation evaluation was performed.A search of the device history record found no related non-conformances reported for lot 14884412.A complaint history database search showed one other related complaints associated with the failure mode for the complaint device for lot 14884412.Due to the individual nature of the manufacturing and inspection process for the devices in the lots, it is unlikely that these events are an indication of device issue within the entire lot.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, it was concluded that there is no evidence that nonconforming product exists in house or in field.Cook also reviewed product labeling.The ifu [t_j-ccrb_rev3; 'cook cervical ripening balloon with stylet'] supplied with the device states the following in consideration of the reported failure mode: "warnings: the product should not be left indwelling for a period greater than 12 hours." "instructions for use: note: the device is not intended to be in place for longer than 12 hours.Time the placement of the device 12 hours prior to the planned induction." the complaint device was not returned; therefore, no functional testing or visual inspections could be performed.Based upon the available information and results of the investigation, cook has concluded that the most probable cause of this event is related to patient factors.The appropriate personnel have been notified and cook will continue to monitor for similar events.Per the quality engineering risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
Additional information received 21sep2023 and 25sep2023: the patients blood was cultured in an attempt to determine the cause of the fever; the 'providencia rettgeri' was also cultured.The patients blood culture result was 'negative'.

• 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
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 17733057
• Report Number: 1820334-2023-01228
• Device Sequence Number: 6093331
• Product Code: PFJ
• UDI-Device Identifier: 00827002481497
• UDI-Public: (01)00827002481497(17)250809(10)14884412
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K131206
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2023

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: 08/09/2025
• Device Catalogue Number: J-CRB-184000
• Device Lot Number: 14884412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/06/2023
• Supplement Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 09/12/2023
• Supplement Report FDA Received Date: 10/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 31 YR
• Patient Sex: Female