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

Model Number G52373

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

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

Event Date 05/09/2023

Event Type  malfunction  

Event Description

As reported, during a procedure intended to treat peripheral arterial occlusive disease in a patient with an ulcer on the left foot.An advance 35 lp low profile balloon catheter's balloon leaked.Another manufacturer's 7-french sheath and 0.035-inch wire were used during the procedure.The anatomy was not tortuous or calcified.The balloon was inflated one time to eight atmospheres within the 60% occluded lesion in the left iliac artery.Using another manufacturer's inflation device.However, the user noted, that the pressure was decreasing, and the balloon leaked.Blood was noted, in the inflation device when the leak occurred.The balloon was not inflated within a stent.The balloon catheter was removed by itself.And another manufacturer's balloon 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, due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects, due to this occurrence.

Manufacturer Narrative

E1: customer name and address= (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.

Manufacturer Narrative

This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.Corrected information: d9, h3: device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet 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.

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 unknown, unchanged, or unavailable.Corrected information: h6 (annex a).Summary of event: as reported, during a procedure intended to treat peripheral arterial occlusive disease in a patient with an ulcer on the left foot, an advance 35 lp low profile balloon catheter's balloon leaked.Another manufacturer's 7-french sheath and 0.035-inch wire were used during the procedure.The anatomy was not tortuous or calcified.The balloon was inflated one time to eight atmospheres within the 60% occluded lesion in the left iliac artery, using another manufacturer's inflation device; however, the user noted that the pressure was decreasing, and the balloon leaked.Blood was noted in the inflation device when the leak occurred.The balloon was not inflated within a stent.The balloon catheter was removed by itself, and another manufacturer's balloon 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 due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), and quality control procedures were conducted during the investigation.A visual inspection and functional test of the complaint device was also conducted.The complaint device was returned to cook for investigation.A leak was noted near the distal end of the balloon.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.The product ifu states "if resistance is met while advancing the balloon dilatation catheter, determine the cause and proceed with caution.¿ the information provided upon review of the dmr, dhr, ifu, and investigation of the returned device 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.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the information provided and the results of the investigation, cook has concluded that the patient¿s anatomy contributed to this event, as the left iliac artery was 60% occluded.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.

Event Description

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

• 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: 16988747
• MDR Text Key: 315839407
• Report Number: 1820334-2023-00642
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10827002523736
• UDI-Public: (01)10827002523736(17)251121(10)CINC002480
• 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,Health Professional,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G52373
• Device Catalogue Number: PTA5-35-80-10-4.0
• Device Lot Number: CINC002480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2022
• 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: BD INFLATION DEVICE.; TERUMO 35 WIRE.; TERUMO 7 FR SHEATH.
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 76 KG