MAUDE Adverse Event Report: COOK INC ADVANCE 18 LP LOW PROFILE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Model Number G50225

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2020

Event Type  malfunction  

Manufacturer Narrative

Occupation = business manager.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 angioplasty of the left subclavian artery, an advance 18 lp low profile balloon catheter was difficult to deflate.The balloon was inflated through a strut of a pre-existing aortic stent, with the goal of coiling the left internal mammary artery.An unknown inflation device and other manufacturer's syringe were used to inflate the balloon, using a stopcock and a 50/50 ratio of visipaque contrast to saline.The balloon was pulled into an unknown sheath, over another manufacturer's wire guide.The stopcock was removed and the user attempted several times to deflate the balloon with the inflation device as well as the other manufacturer's syringe.After several minutes, the balloon was deflated.After removing the device from the patient's body, the user attempted to inflate and deflate the complaint device on the back table; however, experienced the same difficulty with deflation.The procedure was completed successfully, with deployment of a coil in the left internal mammary artery and dilation of the existing aortic stent.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

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Description of event: as reported, during angioplasty of the left subclavian artery, an advance 18 lp low profile balloon catheter was difficult to deflate.The balloon was inflated through a strut of a pre-existing aortic stent, with the goal of coiling the left internal mammary artery.An unknown inflation device and other manufacturer's syringe were used to inflate the balloon, using a stopcock and a 50/50 ratio of visipaque contrast to saline.The balloon was pulled into an unknown sheath, over another manufacturer's wire guide.The stopcock was removed and the user attempted several times to deflate the balloon with the inflation device as well as the other manufacturer's syringe.After several minutes, the balloon was deflated.After removing the device from the patient's body, the user attempted to inflate and deflate the complaint device on the back table; however, experienced the same difficulty with deflation.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, documentation, drawings, the instructions for use, manufacturing instructions, quality control data, and specifications.The complainant returned one used pta4-18-80-4-2 to cook for investigation.Physical examination of the returned device showed that the balloon was received deflated.No visible damage was noted to the device.The balloon was unable to be inflated.The device was soaked in water for 3 days.An attempt to inflate the balloon a second time after soaking was successful, the balloon also deflated without difficulty.No leakage was detected when balloon was inflated.It is suspected that the lumen was occluded which caused the balloon to have difficulty deflating and inflating.A review of the device history record found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows no other complaints associated with the complaint device lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: intended use ¿the advance 18lp low profile balloon dilatation catheter has been designed for percutaneous transluminal angioplasty (pta) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral as a well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae.¿ instructions for use: 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 vacumm on the inflation syringe or inflation device.Maintain vacuum on the balloon and withdraw the catheter.Upon catheter withdrawal, a gentle counterclockwise rotation of the catheter will assist 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.¿ how supplied: ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ a review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Cook has concluded a definitive conclusion could not be determined.It is suspected that the balloon lumen was occluded which caused the balloon to have difficulty deflating and inflating.Per the quality engineering risk assessment, no further action is warranted.Cook 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.

Event Description

No new patient or event information to report.

• Brand Name: ADVANCE 18 LP LOW PROFILE BALLOON CATHETER
• Type of Device: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10579506
• MDR Text Key: 208323114
• Report Number: 1820334-2020-01746
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10827002502250
• UDI-Public: (01)10827002502250(17)230727(10)13328823
• Combination Product (y/n): N
• PMA/PMN Number: K073378
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/27/2023
• Device Model Number: G50225
• Device Catalogue Number: PTA4-18-80-4-2
• Device Lot Number: 13328823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Date Manufacturer Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: V18 WIRE, VACLOC SYRINGE; V18 WIRE, VACLOC SYRINGE
• Patient Age: 4 YR
• Patient Weight: 16