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

Model Number G34325

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

Patient Problem No Code Available (3191)

Event Date 10/15/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant products= cook kcfw-6.0-35-55-rb-hfanl0-hc sheath, boston scientific v-18 control wire m00146850.(b)(4).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, an advance 18 lp low profile balloon catheter ruptured and separated during an angiogram.The balloon was inflated one time, using an unknown inflation device, to eight atmospheres within the popliteal artery when it ruptured within thirty seconds.As the physician was pulling the balloon from the patient, it became caught on a 6 french cook sheath.Because the balloon was unable to be pulled through the sheath, the user removed the balloon, sheath, and other manufacturer's wire from the patient as a unit.A radiopaque marker remained visible on fluoroscopy after the device was removed.The marker, with a portion of the separated balloon material attached, was retrieved from the patient with a hemostat.A ct scan was performed and no additional balloon fragments were found in the patient.The anatomy was not angulated, tortuous or calcified.Blood was not noted in the inflation device.The balloon was not inflated within a stent.A counter-clockwise rotation of the device was not conducted upon removal.Initially, the user had intended to place a stent during the procedure, but elected to bring the patient back at a later date to do so.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

Description of event: as reported, an advance 18 lp low profile balloon catheter ruptured and separated during an angiogram.The balloon was inflated one time, using an unknown inflation device, to eight atmospheres within the popliteal artery when it ruptured within thirty seconds.As the physician was pulling the balloon from the patient, it became caught on a 6 french cook sheath.Because the balloon was unable to be pulled through the sheath, the user removed the balloon, sheath, and other manufacturer's wire from the patient as a unit.A radiopaque marker remained visible on fluoroscopy after the device was removed.The marker, with a portion of the separated balloon material attached, was retrieved from the patient with a hemostat.A ct scan was performed and no additional balloon fragments were found in the patient.The anatomy was not angulated, tortuous or calcified.Blood was not noted in the inflation device.The balloon was not inflated within a stent.A counter-clockwise rotation of the device was not conducted upon removal.Initially, the user had intended to place a stent during the procedure, but elected to bring the patient back at a later date to do so.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 pta4-18-150-4-6 balloon catheter to cook for investigation.Physical examination of the returned device showed biomatter present on the returned device.Inspection found only 1.8cm of the balloon remained on the catheter.The proximal marker band present was present on the returned device.The catheter was received inside a 6fr kcfw sheath.The kcfw sheath did not appear damaged.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 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 a definitive conclusion could not be determined.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: 10726058
• MDR Text Key: 212723375
• Report Number: 1820334-2020-01924
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 10827002343259
• UDI-Public: (01)10827002343259(17)230520(10)13202447
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2023
• Device Model Number: G34325
• Device Catalogue Number: PTA4-18-150-4-6
• Device Lot Number: 13202447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Date Manufacturer Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other