MAUDE Adverse Event Report: COOK INC ADVANCE 35 LP LOW PROFILE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Model Number	G35532
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation = head tech.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 an interventional procedure of the left distal superficial artery at the popliteal, an advance 35 lp low profile balloon catheter ruptured upon the first inflation.The balloon ruptured at "low" atmospheres within seconds of being placed.A 6 french cook ansel sheath was used during the procedure as well as a cook inflation device.The anatomy was moderately calcified.The balloon was removed over the wire guide.Blood was noted within the inflation device when the rupture occurred.The balloon was not inflated within a stent.Another balloon of the same type was used to complete the procedure successfully.During the same procedure, another cook advance 35 lp low profile balloon catheter ruptured.That event will be reported under (b)(4).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
D10- product received on: the device was received on 01oct2020 and was found to not match the device information previously reported.Following clarification, the device information for this event has been modified to match that of the returned device.Investigation - evaluation: (b)(6) from (b)(6) informed cook on (b)(6) 2020 of an incident involving two advance 35 lp low profile balloon catheters.The first balloon (subject of this report) reportedly ruptured at low inflation pressure during a left leg intervention procedure.The balloon was introduced into the patient using a 6fr ansel sheath and advanced to the target lesion at the distal superficial femoral artery at the popliteal.The balloon was inflated once using a cook inflation device to an unknown low pressure and ruptured on the first inflation within seconds of being placed.Blood was noted in the inflation device following the balloon rupture.The patient¿s anatomy was reported to have moderate vessel calcification.The balloon was removed over the wire.A new balloon was opened, and the same difficulty occurred as the balloon ruptured before reaching full inflation pressure (reported under manufacturer report #1820334-2020-01662).Two more balloons were used to complete the procedure successfully.A review of documentation including the drawing, instructions for use (ifu), manufacturing instructions (mi), quality control, and specifications, as well as a visual test and functional inspection of the returned device, was conducted during the investigation.One used pta5-35-135-4-14.0 balloon catheter was returned to cook for evaluation.Upon visual inspection, no visible damage to the device was noted.During a functional test, the balloon was inflated, revealing a pinhole leak near the distal tip.Cook has concluded that this device was manufactured to specification.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the design history file (dhf) showed that this device is both safe and effective for its intended use.A review of the device history record (dhr) was unable to be completed due to a lack of lot information as the reported lot did not match the returned device.Based on the available information, cook has concluded that there is no indication of nonconforming product existing either in house or in field.Cook also reviewed product labeling.The label on the product package indicates that for the pta5-35-135-4-14.0, the nominal inflation pressure is 10atm and the rated burst pressure is 15atm.The compliance card insert details balloon inflation pressures stating that for balloons that measure 4mm in width and 14cm in length, the nominal inflation pressure is 10atm and the rated burst pressure is 15atm.In addition, the product ifu, t_35lp_rev5 ¿advance 35lp low profile pta balloon dilatation catheter,¿ provides the following information to the user related to the reported failure mode: device description: ¿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 35lp 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: ¿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.Based on the information provided, inspection of the returned product, and the results of the investigation, a definitive root cause for this event was unable to be established.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ADVANCE 35 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: 10520977
• Report Number: 1820334-2020-01661
• Device Sequence Number: 3369687
• Product Code: DQY
• UDI-Device Identifier: 10827002355320
• UDI-Public: (01)10827002355320(17)230220(10)10341370
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K091527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2020

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: 02/20/2023
• Device Model Number: G35532
• Device Catalogue Number: PTA5-35-135-4-14.0
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2020
• Initial Date Received by Manufacturer: 09/03/2020
• Supplement Date Received by Manufacturer: 11/23/2020
• Initial Report FDA Received Date: 09/11/2020
• Supplement Report FDA Received Date: 12/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 66