MAUDE Adverse Event Report: COOK INC ADVANCE 18 LP LOW PROFILE BALLOON CATHETER; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number G30970

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2020

Event Type  malfunction  

Manufacturer Narrative

Occupation: radiology tech.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 interventional procedure with atherectomy involving the right superficial femoral artery, a pinhole leak was found at the proximal end of an advance 18 lp low profile balloon catheter's balloon.The leak was found upon inflation of the device, which was being used for post dilation of an unknown stent.The balloon was inflated one time to ten atmospheres, using an 80/20 ratio of saline to omnipaque contrast, with an unknown inflation device.The lesion was reported to be approximately sixty percent occluded; however, no angulation, tortuosity, or calcification was noted.Blood was noted in the inflation device.Although a cook 6 french x 45-centimeter sheath was used during the procedure, the balloon was removed by itself, over an unknown wire guide.The procedure was successfully completed with another 18lp balloon.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 an interventional procedure with atherectomy involving the right superficial femoral artery, a pinhole leak was found at the proximal end of an advance 18 lp low profile balloon catheter's balloon.The leak was found upon inflation of the device, which was being used for post dilation of an unknown stent.The balloon was inflated one time to ten atmospheres, using an 80/20 ratio of saline to omnipaque contrast, with an unknown inflation device.The lesion was reported to be approximately sixty percent occluded; however, no angulation, tortuosity, or calcification was noted.Blood was noted in the inflation device.Although a cook 6 french x 45-centimeter sheath was used during the procedure, the balloon was removed by itself, over an unknown wire guide.The procedure was successfully completed with another 18lp balloon.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, interview of personnel, manufacturing instructions, quality control data, and specifications.The complaint returned one used pta4-18-150-7-20 balloon catheter.Biomatter was present on the returned device.The balloon was inflated and a pinhole leak was detected at the proximal end of balloon.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 one other complaint associated with the complaint device lot.The other complaint (pr 311828) was reported by the same customer for the same failure mode.There are many contributing factors that could have affected these incidents including device storage conditions, device preparation, user technique, and patient¿s anatomy.It is unknown if the causes of the pinhole leak for both incidents are related.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: device description ¿the balloons are manufactured from an extra-thinwall, high-strength, minimally compliant material.Particular care should be taken in handling the balloons to prevent damage.They will inflate to the indicated size parameters when utilizing proper pressure recommendations.Adhere to balloon inflation pressure parameters indicated in the compliance card insert.Refer to label for further information.Use of a pressure gauge is recommended to monitor inflation pressures.¿ intended use ¿the advance 18lp low profile pta 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 well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae.¿ warnings ¿do not exceed rated burst pressure.Rupture of balloon may occur.Adhere to balloon inflation pressure parameters in the compliance card insert.Over-inflation may cause rupture of the balloon, which resultant damage to the vessel wall.Use of a pressure gauge is recommended to monitor inflation pressures.¿ ¿do not use a power injector for balloon inflation or injection of contrast medium through catheter lumen marked ¿distal¿.Rupture may occur.¿ instructions for use: balloon preparation ¿choose a balloon appropriate to lesion length and vessel diameter.¿ ¿upon removal from package, inspect the catheter to ensure no damage has occurred during shipping.¿ balloon introduction and inflation ¿note: if resistance is met while advancing the balloon dilatation catheter, determine the cause and proceed with caution.¿ ¿inflate balloon to desired pressure.Adhere to recommended balloon inflation pressures.(see compliance card insert.)¿ ¿if balloon pressure is lost and/or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit.¿ how supplied ¿store in a dark, dry, cool place.Avoid extended exposure to light.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.There are many contributing factors that could have affected incident including device storage conditions, device preparation, user technique, and patient¿s anatomy.The information provided upon review of complaint file, device history record, complaint history on other lots built using the same balloon raw material, device master record, and design verification testing provide objective evidence to support that the device was manufactured to specification and that there is no evidence that nonconforming product exists in house or in field.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: LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10755560
• MDR Text Key: 214118217
• Report Number: 1820334-2020-01969
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 10827002309705
• UDI-Public: (01)10827002309705(17)230811(10)13362132
• Combination Product (y/n): N
• PMA/PMN Number: K130293
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• 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: 10/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/11/2023
• Device Model Number: G30970
• Device Catalogue Number: PTA4-18-150-7-20
• Device Lot Number: 13362132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Date Manufacturer Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR