MAUDE Adverse Event Report: COOK INC ADVANCE 35 LP LOW PROFILE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Catalog Number PTA5-35-135-8-6.0

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/20/2023

Event Type  malfunction  

Event Description

As reported, during an unspecified procedure involving a patient with cirrhosis, an advance 35 lp low profile balloon catheter's balloon leaked.A cook sheath was used, and a cook angiographic catheter was inserted into the abnormal esophageal-gastric fundal vein and embolization material, described as the appropriate amount of gelatin sponge particles, was slowly injected.The balloon catheter was then advanced over an unspecified wire guide.A pressure pump was used to inflate the balloon two times to eight atmospheres, for fifteen seconds each time; however, the balloon leaked, and blood was noted in the inflation device.The balloon was not inflated within a stent.Another device of the same type was used to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures or experience any adverse effects due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.E1: name and address: address: (b)(4).H3: device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.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.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: ADVANCE 35 LP LOW PROFILE BALLOON CATHETER
• Type of Device: DQY CATHETER, PERCUTANEOUS
• 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: 18358171
• MDR Text Key: 330934301
• Report Number: 1820334-2023-01734
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10827002522807
• UDI-Public: (01)10827002522807(17)260824(10)CINC004895
• Combination Product (y/n): N
• PMA/PMN Number: K091527
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PTA5-35-135-8-6.0
• Device Lot Number: CINC004895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2023
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2023
• 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
• Treatment: HNB-5.0-38-100-P-10S-PIG; RUPS-100
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 70 KG