MAUDE Adverse Event Report: COOK INC ADVANCE 14 LP LOW PROFILE BALLOON CATHETER; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	G50314
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, during angioplasty of a severely calcified, 99-100% occluded lesion within the superficial femoral artery, an advance 14 lp low profile balloon catheter ruptured upon the first inflation.Another manufacturer¿s 6 french sheath was used as well as an unknown inflation device.The balloon was removed by itself and another manufacturer¿s device was used to complete the procedure.No adverse events to the patient have been reported.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Description of event: as reported, during angioplasty of a severely calcified, 99-100% occluded lesion within the superficial femoral artery, an advance 14 lp low profile balloon catheter ruptured upon the first inflation.Another manufacturer¿s 6 french sheath was used as well as an unknown inflation device.The balloon was removed by itself and another manufacturer¿s device was used to complete the procedure.No adverse events to the patient have been reported.Investigation ¿ evaluation.A document based investigation was performed including a review of complaint history, device history record, drawings, the instructions for use, manufacturing instructions, quality control data, and specifications.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest the product was made out of specification.A review of the device history record found no non-conformances related to the reported failure mode.As there are no related non-conformances, adequate inspection activities have been established and there is objective evidence that the dhr was fully executed, and there were no other related complaints from the same lot or built using the same sub-assembly lot that were determined to be related to this failure mode, 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.However, the failure mode for the other complaint was determined to not be related to this incident.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 14lp 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.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.¿ balloon deflation and withdrawal: ¿completely deflate the balloon using an inflation device or syringe.Allow adequate time for the balloon to deflate." "deflate the balloon by pulling vacuum on the inflation syringe or inflation device.Maintain vacuum on the balloon and withdrawal the catheter.Upon catheter withdrawal, a gentle counter-clockwise rotation of the catheter will assist balloon rewrap, minimizing trauma to the percutaneous entry site." "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: ¿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 that the patient¿s anatomy most likely contributed to this incident.As reported, the patient¿s anatomy was severely calcified, and the lesion was 99-100% occluded.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 or Problem Description
No new patient or event information to report.

• Brand Name: ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
• Common Device Name: LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11026914
• Report Number: 1820334-2020-02324
• Device Sequence Number: 18989988
• Product Code: LIT
• UDI-Device Identifier: 10827002503141
• UDI-Public: (01)10827002503141(17)221204(10)10188856
• Combination Product (Y/N): N
• PMA/510(K) Number: K170193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2021

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: 12/04/2022
• Device Model Number: G50314
• Device Catalogue Number: PTAX4-14-170-2-4
• Device Lot Number: 10188856
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2020
• Supplement Date Received by Manufacturer: 03/05/2021
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 03/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1