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

Model Number G34330

Device Problems Material Rupture (1546); Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 07/23/2020

Event Type  Injury  

Manufacturer Narrative

Occupation = lead tech.(b)(6).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 of a 100% occluded lesion in the distal superficial femoral artery, an advance 18 lp low profile balloon catheter ruptured circumferentially and separated.Access was obtained in the left common femoral artery and an antegrade approach was used.A cook sheath and other manufacturer's wire guide were also used during the procedure.The vessel was moderately calcified; however, angulation and tortuosity were not reported.The balloon was inflated one time, using an unknown inflation device, with a 70/30 ratio of visipaque contrast to saline.The inflation pressure at the time of rupture is unknown.Blood was noted in the inflation device after the device ruptured.The balloon was not inflated within a stent.The separated portion of the balloon was removed with a snare in approximately ten minutes.Another balloon was then used to complete the procedure.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.

Event Description

No new patient or event information to report.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Description of event: as reported, during an interventional procedure of a 100% occluded lesion in the distal superficial femoral artery, an advance 18 lp low profile balloon catheter ruptured circumferentially and separated.Access was obtained in the left common femoral artery and an antegrade approach was used.A cook sheath and other manufacturer's wire guide were also used during the procedure.The vessel was moderately calcified; however, angulation and tortuosity were not reported.The balloon was inflated one time, using an unknown inflation device, with a 70/30 ratio of visipaque contrast to saline.The inflation pressure at the time of rupture is unknown.Blood was noted in the inflation device after the device ruptured.The balloon was not inflated within a stent.The separated portion of the balloon was removed with a snare in approximately ten minutes.Another balloon was then used to complete the procedure.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, manufacturing instructions, quality control data, and specifications.The complainant returned one used device to cook for investigation.Biomatter was present on the returned device.Physical examination of the returned device confirmed that the balloon was ruptured circumferentially and received in two pieces.The separated piece of balloon with the proximal marker band was returned attached in a snare used to retrieve the balloon piece.The distal marker band was not visible on the returned device.An introducer was also returned with the snare used to retrieve the balloon piece inside the lumen of the introducer.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 for both otw and ox ¿the balloon is manufactured from an extra-thin wall, 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 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 the balloon rupture.As reported, the vessel was reportedly moderately calcified and 100% occluded.It is unknown if the user adhered to the recommended inflation pressures.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.

• 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: 10351291
• MDR Text Key: 201873724
• Report Number: 1820334-2020-01401
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 10827002343303
• UDI-Public: (01)10827002343303(17)230513(10)13188803
• 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: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/13/2023
• Device Model Number: G34330
• Device Catalogue Number: PTA4-18-150-5-6
• Device Lot Number: 13188803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2020
• Date Manufacturer Received: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COOK 6F 30CM RAABE SHEATH, CSI .014 VIPERWIRE
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR