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

Model Number	G52301
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a procedure involving balloon dilation of a stenosed iliac vein, an advance 35 lp low profile balloon catheter separated.The anatomy was reportedly slightly stenosed.A cook 10-french sheath was also used during the procedure.Per the reporter, an unspecified inflation device was used to inflate the balloon to five atmospheres.The balloon was inflated two times, for two minutes each time, to gradually dilate the lesion, which was reportedly seventy percent occluded.During dilation, the balloon catheter suddenly ¿broke¿ within the vessel.The user is reportedly unsure if the balloon ruptured prior to separation of the catheter; however, blood was not noted in the inflation device.The balloon was not inflated within a stent.Once deflated, the balloon was allowed to return to ambient pressure, and negative pressure was maintained upon attempted removal of the device.The user attempted to remove the balloon catheter and sheath as a unit.A counterclockwise rotation of the balloon was not conducted upon removal.The separated catheter fragments were successfully removed with an unspecified filter retrieval device, via a jugular approach to the inferior vena cava.The procedure was completed with a new balloon catheter.Per the reporter, the procedure went smoothly, without any adverse effects to the patient.A photo provided by the customer shows a separated catheter and balloon, as well as an unspecified filter.Per the reporter, the balloon catheter was not inflated near the filter.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 event.
Additional Manufacturer Narrative
E1: customer name and address = address street and line 2: (b)(6).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.
Additional Manufacturer Narrative
Summary of event: as reported, during a procedure involving balloon dilation of a stenosed iliac vein, an advance 35 lp low profile balloon catheter separated.The anatomy was reportedly slightly stenosed.A cook 10-french sheath was also used during the procedure.Per the reporter, an unspecified inflation device was used to inflate the balloon to five atmospheres.The balloon was inflated two times, for two minutes each time, to gradually dilate the lesion, which was reportedly seventy percent occluded.During dilation, the balloon catheter suddenly ¿broke¿ within the vessel.The user is reportedly unsure if the balloon ruptured prior to separation of the catheter; however, blood was not noted in the inflation device.The balloon was not inflated within a stent.Once deflated, the balloon was allowed to return to ambient pressure, and negative pressure was maintained upon attempted removal of the device.The user attempted to remove the balloon catheter and sheath as a unit.A counterclockwise rotation of the balloon was not conducted upon removal.The separated catheter fragments were successfully removed with an unspecified filter retrieval device, via a jugular approach to the inferior vena cava.The procedure was completed with a new balloon catheter.Per the reporter, the procedure went smoothly, without any adverse effects to the patient.A photo provided by the customer shows a separated catheter and balloon, as well as an unspecified filter.Per the reporter, the balloon catheter was not inflated near the filter.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 event.Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.The complaint device was not returned to cook for investigation; however, a photo and video provided by the customer shows separation of the device.A document-based investigation evaluation was performed.A review of the device history record found no relevant non-conformances on the lot.A review of complaint history found no additional complaints for this lot number.The customer followed relevant instructions in the ifu (instructions for use).A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The information provided upon review of the dmr, dhr, ifu, and inspection of the customer supplied photo and video suggests that there is evidence the device was manufactured to specification.There is no evidence of non-conforming devices in-house or in the field.Based on the information provided and the results of the investigation, cook has concluded that a component failure contributed to this event.Although the user reported that the anatomy was slightly stenosed and the lesion was seventy percent occluded, the balloon was successfully inflated two times.The user followed relevant steps in the ifu and the device was not inflated within a stent.The risk analysis for this failure mode was reviewed and no additional escalation was required.The appropriate personnel have been notified, and cook will continue to monitor for similar events.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: ADVANCE 35 LP LOW PROFILE BALLOON CATHETER
• Common Device Name: 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: 20835847
• Report Number: 1820334-2024-01585
• Device Sequence Number: 3864781
• Product Code: DQY
• UDI-Device Identifier: 10827002523019
• UDI-Public: (01)10827002523019(17)270416(10)CI000009401
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K091527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2025

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 Model Number: G52301
• Device Catalogue Number: PTA5-35-135-12-10.0
• Device Lot Number: CI000009401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2024
• Supplement Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: COOK KCFW-10.0-38-40-RB.
• Patient Age: 60 YR
• Patient Sex: Female