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

Model Number N/A

Device Problem Material Puncture/Hole (1504)

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

Event Date 01/10/2024

Event Type  malfunction  

Event Description

As reported, during a procedure involving ¿balloon stent dilation¿ within a lesion in the femoral artery, a hole was noted in an advance 35 lp low profile balloon catheter¿s balloon.The femoral artery was reportedly stenosed, and the lesion was ninety percent occluded.A cook 6-french sheath was used during the procedure.Using digital subtraction angiography (dsa), another manufacturer¿s 0.035-inch wire and a cook support catheter were used to assist the balloon catheter to reach the location of the lesion.An unspecified pressure pump was used to inflate the balloon with saline and contrast; however, the balloon could not be filled, and blood was noted in the inflation device.The balloon was not inflated within a stent.Upon withdrawal of the device, a small hole was noted in the balloon.A new 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 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: country: china, postal code: (b)(6), phone: (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 or that a death or serious injury occurred; nor is it admission 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 unknown, unavailable or unchanged.Additional information: d9, h3: device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.Correction: b3 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: 18616791
• MDR Text Key: 334302188
• Report Number: 1820334-2024-00145
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10827002522562
• UDI-Public: (01)10827002522562(17)260213(10)CINC003035
• 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,Followup
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: PTA5-35-135-4-14.0
• Device Lot Number: CINC003035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2023
• 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: KCFW-6.0-38-70-RB-RAABE; TERUMO'S 35-260 LOGURIA STIFFEN WIRE GUIDE
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 74 KG