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

Catalog Number J-HFBS-503540

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

As reported, four 'harrison fetal bladder stent sets' were used in an unspecified procedure, as they kept "falling out".Additional information has been requested but is unavailable at this time.

Manufacturer Narrative

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 Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Event description: as reported, four 'harrison fetal bladder stent sets' were used in an unspecified procedure, as they kept "falling out".Additional information has been requested, but no additional information was received.Investigation - evaluation reviews of 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.The available evidence suggests that the device was manufactured to specification.A review of the device history record could not be completed due to lack of lot information from the user facility.A review of complaint history records could not be completed due to lack of lot information from the user facility.A review of the quality procedures associated with this catalog number were examined.Cook has concluded that sufficient inspection activities are in place to assure device functionality prior to distribution.The information provided upon review of complaint file and quality control documents does not provide evidence to support that the device was manufactured out of specification or to suggest similar devices in the field or in house are 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.We will continue to monitor for similar complaints.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
• Type of Device: 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: 18024868
• MDR Text Key: 327258863
• Report Number: 1820334-2023-01476
• Device Sequence Number: 1
• Product Code: MPR
• Combination Product (y/n): N
• PMA/PMN Number: H960001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: J-HFBS-503540
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female