MAUDE Adverse Event Report: COOK INC ADVANCE 14 LP LOW PROFILE BALLOON CATHETER; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number G50317

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/18/2019

Event Type  malfunction  

Manufacturer Narrative

Occupation = non-healthcare professional.Pma/510(k) number = k170193.Investigation ¿ evaluation.Reviews of the complaint history, device history record, drawing, instructions for use (ifu), manufacturer¿s instructions, quality control procedures, and a functional test & visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that the complaint device returned for investigation is consistent with the photos of the complaint device previously provided.Functional testing of the balloon lumen revealed a pinhole rupture between the proximal balloon bond and proximal marker band - in the shoulder area of the balloon.No other damage on the device was noted.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should also be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions, drawings, and quality control procedures were conducted, and no gaps were discovered.Moreover, an ifu is provided with this device which notes that the intended use outlines that the device is 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.It is noted in bold that particular care should be taken in handling the balloon to prevent damage.The warning section states to not exceed the rated burst pressure and is reiterated on the product packaging.The product labeling provides adequate instructions to properly handle the balloon catheter.¿in the event that balloon pressure is lost and/or balloon rupture occurs, the balloon is to be deflated and removed with the sheath as a unit.¿ based on the information provided and the examination of the returned product, investigation has concluded that a root cause for this event could not be established.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.

Event Description

As originally reported, during balloon dilation of the anterior tibial artery, involving a (b)(6) year-old male patient, an advance 14 lp low profile balloon catheter would not inflate past 2 atmospheres.No damage was observed on initial inspection of the device.After flushing, the user advanced the balloon catheter over a pre-positioned cook 0.014 inch wire guide.Per the initial reporter, "negative pressure could only apply to 2 atm/bar" and blood velocity increased under digital subtraction angiography (dsa).The balloon and unknown sheath were removed as a unit and a new cook device was used to complete the procedure successfully.Additional information stated that the customer did not notice any obvious leaks on the device.Another manufacturer's pressure pump with pressure indicator was used to inflate the device, using an unknown contrast agent.The physician clarified that it was difficult to apply pressure/inflate beyond 2 atmospheres.No calcification, angulation, or tortuosity was reported.Upon return and initial investigation of the device, a pinhole rupture was found.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.Provided these details, this event is not considered reportable.Upon return of the device to the manufacturer, and inspection of the device on 16jul2019 however, a "pinhole leak" was observed just proximal to the proximal marker band.

• Brand Name: ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
• Type of Device: LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 8832754
• MDR Text Key: 175672410
• Report Number: 1820334-2019-01814
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 10827002503172
• UDI-Public: (01)10827002503172(17)220220(10)9538102
• Combination Product (y/n): N
• Reporter Country Code: CN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/20/2022
• Device Model Number: G50317
• Device Catalogue Number: PTAX4-14-170-2-12
• Device Lot Number: 9538102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2019
• Date Manufacturer Received: 07/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 64