MAUDE Adverse Event Report: COOK INC HARRISON FETAL BLADDER STENT SET; MPR STENT, BLADDER, FETAL

Catalog Number	J-HFBS-503540
Medical Device Problem Codes	Off-Label Use (1494); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1: customer phone = (b)(6).E3: occupation = lead fetal medicine midwife, fetal medicine.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.
Event or Problem Description
As reported, a 'harrison fetal bladder stent set' was attempted to be used for thoracentesis and pleuro-amniotic shunt placement.During placement, the user attempted to release the pigtail from the trocar twice but the pigtail would not release ((b)(4)/lot 15109821)).The procedure could not be completed, resulting in the need for 3 additional procedures to take place at later, unspecified, dates to drain the excess pleural fluid ((b)(4)/lot 14000403).
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary as reported, a 'harrison fetal bladder stent set' was attempted to be used for thoracentesis and pleuro-amniotic shunt placement.During placement, the user attempted to release the pigtail from the trocar twice but the pigtail would not release (patient id (b)(6)).The procedure could not be completed, resulting in the need for 3 additional procedures to take place at later, unspecified, dates to drain the excess pleural fluid (patient id (b)(6)).Investigation ¿ evaluation: reviews of documentation including the review of complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures, as well as a visual inspection of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhr for the reported complaint device lot revealed no recorded non-conformances relevant to the failure mode.A database search did not identify any other complaints associated with the reported device lot.The information provided upon review of complaint file, device history record, complaint history, and quality control documents did not provide evidence to support that the device was manufactured out of specification or to suggest items in the lot or similar devices in the field or in house were nonconforming.Cook also reviewed product labeling.The product ifu, [tfbfbp_rev1] ¿harrison fetal bladder stent set¿ contains the following information related to the reported failure mode.¿assembly instructions 1.Just prior to the placement procedure, load the positioner onto the wire guide.2.Load the stent onto the wire guide by introducing the wire guide into the multi-length coil of the stent until 3mm- 4mm of the wire guide extends beyond the distal coil of the stent.Place non-flared end of the positioner against the end of the multi-length (proximal) stent coil¿¿ ¿implanting harrison fetal bladder stent.¿ 4.Trocar tip should be advanced 5mm -10cm into the fetal bladder.¿ 5.While stabilizing the needle, advance the stent assembly into the needle.6.After the positioner has entered the hub of the needle and is within the needle cannula, stabilize the positioner and remove the wire guide.¿ based on the available information, no product returned, and the results of the investigation, the cause of the incident was unable to be determined.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the 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.

• Brand Name: HARRISON FETAL BLADDER STENT SET
• Common Device Name: MPR STENT, BLADDER, FETAL
• 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: 17714045
• Report Number: 1820334-2023-01119
• Device Sequence Number: 6749440
• Product Code: MPR
• UDI-Device Identifier: 00827002167667
• UDI-Public: (01)00827002167667(17)251205(10)15109821
• Combination Product (Y/N): N
• PMA/510(K) Number: H960001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/05/2025
• Device Catalogue Number: J-HFBS-503540
• Device Lot Number: 15109821
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2023
• Supplement Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 03/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2022
• 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 Sex: Female