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

Model Number	G30897
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant products= philips pioneer catheter, 014 roadrunner, merit 5/6fr sheath.Reporter occupation = lab manager.(b)(4).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 for a chronic total occlusion of the left superficial femoral artery, an advance 18 lp low profile balloon catheter ruptured and separated.The lesion was crossed using another manufacturer's catheter and the lesion was pre-dilated with a cook 2x6 18lp balloon.The complaint device was then inserted over a cook 0.014 inch roadrunner wire guide.The balloon was inflated to approximately five or six atmospheres using a 50/50 ratio of omnipaque contrast to saline, at which point the balloon ruptured.The user then attempted to remove the balloon over the wire; however, it became stuck, possibly within the heavily calcified lesion, and separated.The sheath and balloon catheter were removed as a unit.The distal marker and separated portion of the balloon were left in the body, wrapped around the wire guide.A 6x13 cook performer sheath was then inserted and the user removed the separated portion of the device by pulling the wire guide and balloon fragment through the sheath.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.
Additional Manufacturer Narrative
Description of event: as reported, during an interventional procedure for a chronic total occlusion of the left superficial femoral artery, an advance 18 lp low profile balloon catheter ruptured and separated.The lesion was crossed using another manufacturer's catheter and the lesion was pre-dilated with a cook 2x6 18lp balloon.The complaint device was then inserted over a cook 0.014 inch roadrunner wire guide.The balloon was inflated to approximately five or six atmospheres using a 50/50 ratio of omnipaque contrast to saline, at which point the balloon ruptured.The user then attempted to remove the balloon over the wire; however, it became stuck, possibly within the heavily calcified lesion, and separated.The sheath and balloon catheter were removed as a unit.The distal marker and separated portion of the balloon were left in the body, wrapped around the wire guide.A 6x13 cook performer sheath was then inserted and the user removed the separated portion of the device by pulling the wire guide and balloon fragment through the sheath.Investigation ¿ evaluation a visual inspection 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 complainant returned one used pta4-18-80-4-20 catheter.Physical examination of the returned device showed that the catheter was separated into two pieces.Inner lumen material of the balloon was elgogated.The proximal marker band was present on the proximal end of the device.The balloon was ruptured circumferentially.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: 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 capa was previously completed to address the increasing trend of balloon rupture for pta4 and pta5 devices.The capa identified the following root causes: inadequate preventive maintenance (pm) of folding equipment, inadequate process controls for folding and bonding processes, and inadequate qc work instructions for inspection microtears.The following corrective actions were taken to address the identified root causes.Preventive maintenance requirements for msi folding equipment were updated and added to maintenance connection.Additionally, process controls requirements were changed in order to include improved conditions for inspections (higher magnification, higher inflation pressure) and additional pictures of microtears were added to qc work instructions.The complaint device was manufactured prior to the conclusion of capa implementation actions.Based on the condition of the returned device, it cannot be confirmed that the root causes identified in the capa are related to this incident.Cook has concluded that the patient¿s anatomy most likely contributed to this incident.As reported, the complaint device was used within a chronic total occlusion, and the user suspected that the ruptured balloon became stuck on a heavily calcified lesion, subsequently separating.It is also possible that the inadequate manufacturing related controls identified as the root causes in the capa could be related to this incident, however based on device return this cannot be confirmed.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 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: 10706673
• Report Number: 1820334-2020-01907
• Device Sequence Number: 14514687
• Product Code: LIT
• UDI-Device Identifier: 10827002308975
• UDI-Public: (01)10827002308975(17)211009(10)9222176
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/09/2021
• Device Model Number: G30897
• Device Catalogue Number: PTA4-18-80-4-20
• Device Lot Number: 9222176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Initial Date Received by Manufacturer: 10/09/2020
• Supplement Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 02/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR