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

Model Number G16766

Device Problems Difficult to Advance (2920); Material Twisted/Bent (2981)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was originally reported the customer had problems with two harrison fetal bladder stent sets.The problem was with the pushers.It was not possible to insert the stent to the end of the needle, nor to reach the first mark on the positioner.This first case reports the attempt to place the harrison fetal bladder stent set in the chest space near a solid tumor (reported in patient identifier (b)(6)).The second case (patient identifier (b)(6)) reports the attempt to place the harrison fetal bladder stent set under ideal pre-requisites(fetal status, simple passage through the uterine cavity, easy insertion of the needle into the peritoneal cavity of the fetus).Additional information received clarifies that both procedures (harrison fetal bladder stent placement in the chest space near a solid tumor (reported in patient identifier (b)(6)) and harrison fetal bladder stent placement in the peritoneum to drain fetal ascites (281969) were performed on the same fetus and mother-(this report).All steps were performed according to the instructions.After practicing the procedure on the practice copy of the set, the procedure was performed in the same way as previously successful procedures.The stent was placed on the guide just before the needle was inserted.Any attempt tp move the positioner resulted in "inelastic resistance" and bending of the positioner.Proximal stent distension was found, as if the positioner would go inside the stent instead of pushing it in.When introducing the stent assembly into the needle cup, "i felt subjectively more resistance than usual." the second procedure (harrison fetal bladder stent placement into the peritoneal cavity to drain fetal ascites ) was performed at 30w +2 days gestation (8 days after the first procedure).The estimated fetal weight at the time was 2195gm.This was thought to be inaccurate due to the presence of fetal hydrops.Amniotic fluid index (afi) was 30.The physician reported the procedure was partially completed, described as partial single ascites reduction only and amnioreduction.An unknown time interval after this procedure, there was a placental abruption necessitating an emergency cesarean delivery (premature) delivery about a week earlier than was planned.No additional consequences to the mother have been reported.On (b)(6) 2019 the baby and mother are reported to both be "fine".

Event Description

No additional patient or event information has been provided since the last report was submitted on 03dec2019.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation.A visual inspection of the returned device could not be conducted as the device was not returned.A document based investigation was performed including a review of complaint history, the device history record, instructions for use, manufacturing instructions, and quality control data.A review of the device history record revealed no non-conformances related to the reported failure.A review of complaint records for the reported lot revealed two other complaint received from the same customer, reported at the same time of this complaint.In response to this incident, cook completed a review of the product dmr.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A complaint device was not returned for this complaint.A partial harrison fetal bladder stent set was returned for patient identifier 281689 (reported by the same customer at the same time as this event for same difficultly with advancement).The findings from pr281689 device failure analysis were no manufacturing anomalies were noted with the returned components.The positioner component which was alleged to have bent was not returned.Cook has reviewed the ifu for this device and it provides the following information to the user related to the reported failure mode: the harrison fetal bladder stent set is intended for use in fetal urinary tract decompression following the diagnosis of fetal post-vesicular obstructive uropathy in fetuses of 18 to 32 weeks of gestational age.The ifu includes the following warnings: 1.Implantation of the harrison fetal bladder stent may result in leakage of amniotic fluid and/or complete rupture of the membranes.2.Implantation of the harrison fetal bladder stent carries the possible risk of infection and the development of chorioamnionitis.This could lead to the need for intervention, including termination of pregnancy, and in rare cases, loss of the uterus.3.The procedure to implant the harrison fetal bladder stent carries the risk of premature labor which could lead to premature delivery, and in rare cases damage to the uterus.4.Once the stent is placed, there is a possibility that it may become obstructed or dislodged, resulting in the need for repeated stent placements.5.The harrison fetal bladder stent is designed and intended for decompression of the fetal urinary tract.There are no data regarding this stent¿s safety and effectiveness in decompressing, draining or treating other fetal cavities or conditions.The ifu includes potential adverse events and side effects associated with the use of the stent could include: preterm labor.Uterine injury or bleeding, placental bleeding.Conclusion: the harrison fetal bladder stent set for this complaint set was not returned.A similar complaint reported at the same time as this one by the same customer (also for difficulty in advancement) had a partial harrison fetal bladder stent set returned.The findings from that complaint (patient identifier (b)(6) were no manufacturing anomalies were noted with the returned components.The positioner component which was alleged to have bent was not returned.A review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.A clinical evaluation of this complaint found with the information available, the likely causative factors of this event include off label use of the device, and the high-risk nature of this procedure.Per the quality engineering risk assessment, no additional risk mitigating activity is required.Cook medical has notified the appropriate personnel and 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: HARRISON FETAL BLADDER STENT SET
• Type of Device: MPR STENT, BLADDER, FETAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9402556
• MDR Text Key: 168889183
• Report Number: 1820334-2019-03002
• Device Sequence Number: 1
• Product Code: MPR
• UDI-Device Identifier: 00827002167667
• UDI-Public: (01)00827002167667(17)220228(10)9558830
• Combination Product (y/n): N
• PMA/PMN Number: H960001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 01/22/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: G16766
• Device Catalogue Number: J-HFBS-503540
• Device Lot Number: 9558830
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/13/2019
• Initial Date FDA Received: 12/03/2019
• Supplement Dates Manufacturer Received: 01/15/2020
• Supplement Dates FDA Received: 01/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Required Intervention
• Patient Age: 32 YR
• Patient Weight: 58