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

Catalog Number	PTA5-35-80-4-4.0
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Codes	No Clinical Signs, Symptoms or Conditions (4582); Reduced Blood Flow (4598)
Date of Event	03/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: customer name and address = 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, 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 or Problem Description
As reported, during an unspecified procedure, an advance 35 lp low profile balloon catheter was unable to pass through a lesion within the superficial femoral artery (sfa).The mid-sfa lesion was described as a highly calcified, chronic total occlusion.A contralateral approach was used from the "inguinal region".The bifurcation angle was not tight, and the anatomy was not tortuous; however, the anatomy was calcified.Another manufacturer's 6-french sheath was used, as well as another manufacturer's wire guide.Reportedly, the physician wanted to change to a 0.035-inch wire during the procedure, but could not do so.The device was flushed before the procedure, per the instructions for use.After the balloon catheter (complaint device) was unable to cross the severely calcified lesion, another manufacturer's 3-millimeter balloon catheter was able to cross the lesion; however, that device failed to dilate the lesion.The user then decided to dilate the lesion after placing a stent; however, the stent delivery system was unable to pass through to the target site.During the procedure, blood flow "stopped"; therefore, the procedure was converted to a femoral-to-popliteal bypass and completed.The patient recovered.A section of the device did not remain inside the patient¿s body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.B1, h1: additional information received 14apr2024 stated that the complaint device was unable to be advanced at all and therefore, it did not cause the femoral-popliteal bypass procedure.As such, this complaint is no longer reportable.Per a search of risk documentation and previous complaint data, there is no evidence to suggest that difficult advancement of this device would be likely to cause or contribute to a death or a serious injury if the failure were to recur.Furthermore, there is no evidence that the device caused or contributed to a serious injury in this case, as no life-threatening or permanently impairing injury was alleged, nor was intervention taken as a result of the device failure which would be required to prevent permanent impairment or damage to the patient.As such, the event is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury, or reportable product malfunction.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 or Problem Description
Additional information was received 14apr2024.The user stated that the complaint device was unable to be advanced at all, and therefore, it was not the cause of the femoral-popliteal bypass.

• 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: 19087265
• Report Number: 1820334-2024-00502
• Device Sequence Number: 7128119
• Product Code: DQY
• UDI-Device Identifier: 10827002523323
• UDI-Public: (01)10827002523323(17)260424(10)CINC003348
• Combination Product (Y/N): N
• PMA/510(K) Number: K091527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/24/2026
• Device Catalogue Number: PTA5-35-80-4-4.0
• Device Lot Number: CINC003348
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2024
• Supplement Date Received by Manufacturer: 04/14/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2023
• 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: ASAHI INTECC GLADIUS WIRE; BOSTON SCIENTIFIC COYOTE BALLOON CATHETER; TERUMO DESTINATION 6FR SHEATH; ZISV6-35-125-6.0-80-PTX
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown