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); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E3: occupation = professor.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, during villus chorionic sampling, three harrison fetal bladder stents got stuck in the needle/trocar.No section of the device remained inside the patient¿s body.The patient did not require additional procedures due to this occurrence.According to the initial reporter, the patient did not experience adverse effects due to this occurrence.Additional information has been requested regarding the event.At the time of this report, no further information has been provided.
Additional Manufacturer Narrative
Event description: as reported, during villus chorionic sampling, three harrison fetal bladder stents got stuck in the needle/trocar.No section of the device remained inside the patient¿s body.The patient did not require additional procedures due to this occurrence.According to the initial reporter, the patient did not experience adverse effects due to this occurrence.Additional information has been requested regarding the event.Despite an abundance of attempts to obtain additional information, no response was received.Investigation - evaluation.Reviews of complaint history, device history record (dhr), instructions for use (ifu) and quality control procedures 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.There is no evidence to suggest this device was manufactured out of specification.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to assure device functionality prior to distribution.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows one other related complaint associated with the complaint device lot.The information provided upon review of complaint file, device history record, complaint history, and quality control documents does 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.The instructions for use (ifu), provides the following information to the user 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.¿ the cause of the incident was unable to be determined.Per the quality engineering risk assessment, no further action is required.The appropriate personnel have been notified, and we will continue to monitor 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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 17849351
• Report Number: 1820334-2023-01315
• Device Sequence Number: 14553276
• Product Code: MPR
• UDI-Device Identifier: 00827002167667
• UDI-Public: (01)00827002167667(17)260103(10)15143850
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2024

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 Expiration Date: 01/03/2026
• Device Catalogue Number: J-HFBS-503540
• Device Lot Number: 15143850
• Was Device Available for Evaluation?: Yes
• 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: 01/30/2024
• Initial Report FDA Received Date: 10/01/2023
• Supplement Report FDA Received Date: 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2023
• 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
• Patient Sex: Female