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

Model Number	N/A
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2024
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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 or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional 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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Summary of event: 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.Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), drawing, and quality control procedures were conducted during the investigation.A functional test and visual inspection of the returned device was conducted as well.The complaint device was returned to cook for investigation.The balloon leaked and a pinhole was noted near the proximal balloon bond.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 product ifu states, ¿under fluoroscopy, advance the balloon to the lesion site.Note: ensure that exchange port remains inside the sheath (e.G., that the wire guide does not protrude from the distal end of sheath.) carefully position the balloon across the lesion using the distal and proximal radiopaque markers.Note: if resistance is encountered while advancing the balloon dilatation catheter, determine the cause and proceed with caution.¿ 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, returned device, and complaint file 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 patient anatomy was the cause of the device failure in this incident.The anatomy was stenosed, and the lesion was ninety percent 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.

• 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: 18616791
• Report Number: 1820334-2024-00145
• Device Sequence Number: 15330806
• Product Code: DQY
• UDI-Device Identifier: 10827002522562
• UDI-Public: (01)10827002522562(17)260213(10)CINC003035
• Combination Product (Y/N): N
• PMA/510(K) Number: K091527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/15/2024

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 Expiration Date: 02/13/2026
• 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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/16/2024
• Supplement Date Received by Manufacturer: 03/14/2024; 04/17/2024
• Initial Report FDA Received Date: 01/31/2024
• Supplement Report FDA Received Date: 03/29/2024; 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2023
• 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: 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