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

Model Number	G30946
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: lab manager.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 an interventional procedure of an 100% occluded superficial femoral artery, an advance 18 lp low profile balloon catheter ruptured at eight atmospheres.The balloon had been inflated three times within a vessel that was noted to be very fibrotic with a 50/50 solution of heparinized saline and omnipaque contrast before balloon rupturing at 8atm.The balloon was noted to be inserted, inflated, deflated, removed, reinserted, and re-inflated during the procedure.The ruptured balloon was removed by itself.Blood was noted in the inflation device after rupture.The balloon was not inflated within a stent.No angulation or tortuosity were reported.Another balloon was opened to complete the procedure.No portion of the device was left inside the patient.This did not result in any additional procedures or prolonged hospitalization.No adverse effects to the patient occurred.
Additional Manufacturer Narrative
Investigation ¿ evaluation as reported, during an interventional procedure of a 100% occluded superficial femoral artery, an advance 18 lp low profile balloon catheter ruptured at eight atmospheres.The balloon had been inflated three times within a vessel that was noted to be very fibrotic with a 50/50 solution of heparinized saline and ominpaque contrast before balloon rupturing at 8atm.The balloon was noted to be inserted, inflated, deflated, removed, reinserted, and re-inflated during the procedure.The ruptured balloon was removed by itself.Blood was noted in the inflation device after rupture.The balloon was not inflated within a stent.No angulation or tortuosity were reported.Another balloon was opened to complete the procedure.A review of the complaint history, documentation, device history record, drawing, instructions for use, manufacturing instructions, quality control data, and specifications of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows one other complaint associated with the complaint device lot.The other complaint was reported for a balloon that would not inflate due to a pinhole and it was concluded that the cause of the balloon rupture was attributed to the patient's anatomy which most likely compromised the balloon material, leading to a pinhole.As reported for this case, the balloon was inflated and deflated 2 times prior to rupture on the 3rd attempted inflation.As the first two inflations occurred without rupture, there is no evidence that the device was manufactured out of specification.Therefore, there is no evidence suggesting that the cause for these incidents is related to a manufacturing issue.As 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 have been received from the field, it was concluded that there is no evidence that nonconforming product exists either in house or in field.Cook also reviewed product labeling.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: device description for both otw and ox ¿the balloon is manufactured from an extra-thinwall, high-strength, minimally compliant material.Particular care should be taken in handling the balloon to prevent damage.It 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 is indicated for percutaneous transluminal angioplasty (pta) of lesions 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.¿ precautions ¿the catheter is not intended for the delivery of stents.¿ ¿all stents should be deployed in accordance with the manufacturer¿s indications and instructions for use.¿ 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 for otw balloons ¿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 ¿upon catheter withdrawal, a gentle counterclockwise 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 capa was previously completed to address the increasing trend of balloon rupture for pta4 and pta5 devices.The complaint device was manufactured prior to the conclusion of capa implementation actions.However, in this case, as the first two inflations occurred without rupture, it is believed that the inadequate manufacturing related controls identified as the root causes in the capa are most likely not related to this incident.Per the quality engineering risk assessment, no further action is warranted.Cook has concluded that the patient¿s anatomy most likely contributed to this incident.The lesion was reported to be 100% occluded with the patient¿s anatomy reported to be very fibrotic.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 18 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: 10413433
• Report Number: 1820334-2020-01501
• Device Sequence Number: 16755424
• Product Code: LIT
• UDI-Device Identifier: 10827002309460
• UDI-Public: (01)10827002309460(17)220625(10)9834032
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K130293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2020

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: 06/25/2022
• Device Model Number: G30946
• Device Catalogue Number: PTA4-18-150-3-20
• Device Lot Number: 9834032
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/04/2020
• Supplement Date Received by Manufacturer: 11/06/2020
• Initial Report FDA Received Date: 08/17/2020
• Supplement Report FDA Received Date: 11/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6X45 ANSEL SHEATH.
• Patient Age: 86 YR