MAUDE Adverse Event Report: COOK INC ADVANCE 18 LP LOW PROFILE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Model Number	G50242
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter name and address, phone: (b)(6).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 popliteal artery angioplasty, three advance 18 lp low profile balloon catheters ruptured consecutively in a patient with calcified vessels.The devices burst at 13, 14, and 12 atm.The two other ruptured devices are reported under patient identifiers 328123 and 328128.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.
Additional Manufacturer Narrative
This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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.
Event or Problem Description
Additional information was received 28apr2021.The complaint device "punctured" rather than "split".The balloon was not inflated within a stent.Blood was noted in the inflation device upon rupture.The patient had severe irregular calcific atherosclerotic disease.
Event or Problem Description
No new patient or event information to report.
Additional Manufacturer Narrative
Description of event: as reported, during a popliteal artery angioplasty, three advance 18 lp low profile balloon catheters ruptured consecutively in a patient with calcified vessels.The devices burst at 13, 14, and 12 atm.The complaint device "punctured" rather than "split".The two other ruptured devices are reported under manufacturer report # 1820334-2021-01172 and 1820334-2021-01174.The balloon was not inflated within a stent.Blood was noted in the inflation device upon rupture.The patient had severe irregular calcific atherosclerotic disease.Investigation ¿ evaluation: a document based investigation was performed including a review of complaint history, device history record, drawings, the instructions for use, manufacturing instructions, quality control data, and specifications.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest the product was made out of specification.A review of the device history record found one non-conformances relevant to the reported failure mode.Although this non-conformance is relevant to the reported failure mode, all non-conforming product was scrapped, and there are 100% inspections to capture this non-conformance.A review of complaint history records shows no other complaints associated with the complaint device lot.As 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 non-conforming product exists in house or in field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: 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.¿ 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.¿ 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 patient anatomy contributed to this incident, as the user reported that the patient had very heavy irregular calcific atherosclerotic disease.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: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11694336
• Report Number: 1820334-2021-01173
• Device Sequence Number: 19578322
• Product Code: DQY
• UDI-Device Identifier: 10827002502427
• UDI-Public: (01)10827002502427(17)231118(10)13565616
• Combination Product (Y/N): N
• PMA/510(K) Number: K073378
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/13/2021

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: 11/18/2023
• Device Model Number: G50242
• Device Catalogue Number: PTA4-18-80-5-10
• Device Lot Number: 13565616
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/08/2021
• Supplement Date Received by Manufacturer: 04/28/2021; 07/07/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 05/12/2021; 07/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1