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

Model Number G52265

Device Problems Material Puncture/Hole (1504); Material Rupture (1546)

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

Event Date 04/04/2022

Event Type  malfunction  

Manufacturer Narrative

Occupation: lead tech.Device evaluated by mfg: device evaluation has begun; however, a conclusion is not yet available.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, during an aortic-iliac-femoral intervention, an advance 35 lp low profile balloon catheter ruptured.A cook 6 french x 55-centimeter hi-flex straight ansel sheath was used during the procedure, as well as a cook sphere inflation device.Access was gained in the right iliac artery and a contralateral approach was used.The vessels were reportedly tortuous, calcified, and very small.Upon the initial inflation to pre-dilate the 85% occluded lesion, prior to placing a stent, the balloon reportedly ruptured on a piece of calcium within the distal left superficial femoral artery.Blood was noted in the inflation device at the time of rupture.The balloon was removed by itself, over an unknown wire guide.Another manufacturer's balloon was then used; however, this balloon also ruptured.A third (other manufacturer's) balloon was used to complete the intended procedure.The complaint device was not inflated within a stent prior to rupturing.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.

Event Description

Additional information was received 04may2022.The exact inflation pressure is unknown; however, the device reportedly ruptured below the rated burst pressure.

Manufacturer Narrative

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 Description

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

Manufacturer Narrative

Correction: h6 (annex a).Event summary as reported, during an aortic-iliac-femoral intervention, an advance 35 lp low profile balloon catheter ruptured.The exact inflation pressure is unknown; however, the device reportedly ruptured below the rated burst pressure.A cook 6 french x 55-centimeter hi-flex straight ansel sheath was used during the procedure, as well as a cook sphere inflation device.Access was gained in the right iliac artery and a contralateral approach was used.The vessels were reportedly tortuous, calcified, and very small.Upon the initial inflation to pre-dilate the 85% occluded lesion, prior to placing a stent, the balloon reportedly ruptured on a piece of calcium within the distal left superficial femoral artery.Blood was noted in the inflation device at the time of rupture.The balloon was removed by itself, over an unknown wire guide.Another manufacturer's balloon was then used; however, this balloon also ruptured.A third (other manufacturer's) balloon was used to complete the intended procedure.The complaint device was not inflated within a stent prior to rupturing.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 a visual inspection and functional testing of the returned device was conducted.A document-based investigation was also performed including a review of complaint history, device history record (dhr), drawing, the instructions for use, specifications, and quality control data.The complainant returned one advance 35 lp low profile balloon catheter to cook for investigation.Physical examination and functional testing of the returned device revealed that a pinhole leak was present on the balloon near the distal tip.Cook reviewed the dhr.The dhr for the related device lot number records 1 relevant nonconformance for 1 device with general balloon damage; however, the nonconforming device was scrapped, and the lot is inspected 100%.A database search for complaints reported on the complaint lot reveal no additional complaints at this time.Therefore, cook determined that no nonconforming product exists in house or in the field.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: balloon introduction and inflation "f balloon pressure is lost and/or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit." balloon deflation and withdrawal "1.Completely deflate the balloon using an inflation device or syringe.Allow adequate time for the balloon to deflate.Note: balloons with large diameters and/or longer lengths may require longer deflation times.2.Deflate the balloon by pulling a vacuum on the inflation syringe or inflation device.Upon catheter withdrawal, a gentle counterclockwise rotation of the catheter will assist in balloon rewrap, minimizing trauma to the percutaneous entry site.3.If resistance is met during withdrawal, apply negative pressure with a larger syringe before proceeding.If resistance continues, remove balloon and sheath as a unit." cook concluded that patient anatomy caused this incident.The user stated that the vessel had calcification, tortuosity, and approximately 85% occlusion.The user also stated, "the balloon burst on a piece of calcium during inflation,¿ which is congruent with cook¿s investigation findings.It is likely that calcification caused the pinhole in the balloon.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database for similar complaints.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 ; 8128294891
• MDR Report Key: 14136979
• MDR Text Key: 289683269
• Report Number: 1820334-2022-00603
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10827002522654
• UDI-Public: (01)10827002522654(17)250118(10)14477433
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091527
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G52265
• Device Catalogue Number: PTA5-35-135-6-4.0
• Device Lot Number: 14477433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2022
• 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: BARD BD BALLOON.; TERUMO BALLOON.
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Weight: 70 KG