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

Model Number	G34332
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation has begun; however, a conclusion is not yet available.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, an advance 18 lp low profile balloon catheter ruptured.The device was advanced to a 40-50% occluded superficial femoral artery using a 5fr ansel sheath.The vessel was moderately calcified but not angulated or tortuous.The device was inflated to 8 atmospheres using an inflation device when it ruptured.The device was removed from the patient, and the procedure was completed using another device of the same type.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence.
Event or Problem Description
No new patient or event information to report since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, an advance 18 lp low profile balloon catheter ruptured.The device was advanced to a 40-50% occluded superficial femoral artery using a 5fr ansel sheath.The vessel was moderately calcified but not angulated or tortuous.The device was inflated to 8 atmospheres using an inflation device when it ruptured.The device was removed from the patient, and the procedure was completed using another device of the same type.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence.Investigation evaluation: reviews of the complaint history, device history record, drawings, instructions for use (ifu), quality control procedures, and specifications were conducted during the investigation.A visual inspection of the returned device was also conducted.The device was returned to cook for investigation.Physical testing and evaluation of the returned device revealed a tiny pinhole leak observed near the balloon midpoint when using water to inflate the balloon.Cook reviewed the device history record (dhr).The dhr for the reported lot records no relevant nonconformances.The raw balloon component was used in the complaint final lot and 3 other final lots.1 final lot records a relevant nonconformance for balloon damage, but the nonconforming product was scrapped, and the lot is inspected 100%.The other 2 lots record no relevant nonconformances.A database search for related complaints on the complaint lot revealed 1 related complaint.This related complaint concluded patient anatomy contributed to that incident.Although there is a lot related complaint that is relevant to the reported failure mode, there are 100% inspections to capture this non-conformance prior to distribution.As adequate inspection activities have been established and there is objective evidence that the dhr was fully executed, it was concluded that there is no evidence of non-conforming product from this lot exists in house or in the field.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook also reviewed the product labeling.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.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.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 vacuum 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 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.¿ cook concluded that patient anatomy was the cause of this incident.The customer reported that moderate calcification of the vessels and cook asserts likely caused the pinhole leak.The appropriate personnel have been notified and cook will continue to monitor for similar events.Per the quality engineering risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• 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
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 12352684
• Report Number: 1820334-2021-02034
• Device Sequence Number: 3383107
• Product Code: LIT
• UDI-Device Identifier: 10827002343327
• UDI-Public: (01)10827002343327(17)231123(10)13583081
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2022

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: 11/23/2023
• Device Model Number: G34332
• Device Catalogue Number: PTA4-18-150-5-10
• Device Lot Number: 13583081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2021
• Supplement Date Received by Manufacturer: 12/21/2021
• Initial Report FDA Received Date: 08/23/2021
• Supplement Report FDA Received Date: 01/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5FR ANSEL SHEATH; 5FR ANSEL SHEATH
• Patient Sex: Unknown