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

Model Number	G30958
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reporter occupation: other non-healthcare professional: office 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 a percutaneous transluminal angioplasty of the left superficial femoral artery (sfa), an advance 18 lp low profile balloon catheter ruptured and separated.The patient¿s anatomy was extremely calcified; however, was not tortuous or angulated.The entire left sfa was diseased and eighty to ninety-five percent occluded, with a short (approximately 60mm) area of chronic total occlusion.The balloon was inflated three times to nominal pressure with an unknown inflation device and a 50/50 ratio of contrast to saline for approximately 30 to 40 seconds.The balloon did not go over burst pressure.The balloon was not removed and reinserted between inflations.After the balloon ruptured, the user attempted to pull the balloon off an unknown wire guide and into a cook sheath, using a counter-clockwise rotation; however, two-thirds of the balloon would not enter the sheath.The user continued to pull on the device and approximately ten to fifteen millimeters of the balloon separated and remained on the wire guide.A cook clover snare was then used to retrieve the separated portion of the balloon from the patient, via the left groin.The balloon was not inflated within a stent.Negative pressie was not maintained continuously during removal of the complaint device, as blood was noted in the inflation device.
Event or Problem Description
No new patient or event information to report.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Description of event: as reported, during a percutaneous transluminal angioplasty of the left superficial femoral artery (sfa), an advance 18 lp low profile balloon catheter ruptured and separated.The patient¿s anatomy was extremely calcified; however, was not tortuous or angulated.The entire left sfa was diseased and eighty to ninety-five percent occluded, with a short (approximately 60mm) area of chronic total occlusion.The balloon was inflated three times to nominal pressure with an unknown inflation device and a 50/50 ratio of contrast to saline for approximately 30 to 40 seconds.The balloon did not go over burst pressure.The balloon was not removed and reinserted between inflations.After the balloon ruptured, the user attempted to pull the balloon off an unknown wire guide and into a cook sheath, using a counter-clockwise rotation; however, two-thirds of the balloon would not enter the sheath.The user continued to pull on the device and approximately ten to fifteen millimeters of the balloon separated and remained on the wire guide.A cook clover snare was then used to retrieve the separated portion of the balloon from the patient, via the left groin.The balloon was not inflated within a stent.Negative pressie was not maintained continuously during removal of the complaint device, as blood was noted in the inflation device.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 pta4-18-150-5-20 balloon catheter to cook for investigation.Biomatter present on the returned device.Physical examination of the returned device showed that the balloon was ruptured circumferentially with approximately 9cm of balloon material was present on catheter.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.¿ balloon deflation and withdrawal.¿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.¿ ¿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.¿ ¿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 the patient¿s anatomy and the procedure contributed to this incident.As reported, the balloon was able to be inflated three times to nominal pressure with rupture occurring on the third inflation.The patient¿s anatomy was extremely calcified with 80-95% of the left sfa occluded, additionally an area of complete occlusion was reported.After the device ruptured, the user continued to pull on the device, despite meeting resistance.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
• Common Device Name: LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10828186
• Report Number: 1820334-2020-02077
• Device Sequence Number: 4123517
• Product Code: LIT
• UDI-Device Identifier: 10827002309583
• UDI-Public: (01)10827002309583(17)230902(10)13404239
• 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): 02/11/2021

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: 09/02/2023
• Device Model Number: G30958
• Device Catalogue Number: PTA4-18-150-5-20
• Device Lot Number: 13404239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2021
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 11/12/2020
• Supplement Report FDA Received Date: 02/11/2021
• 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: 80 YR