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

Model Number	G30955
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) number = k130293.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 post stent angioplasty in the distal superficial femoral artery (sfa) involving a (b)(6) year-old male patient with occlusion of the sfa, an advance 18 lp low profile balloon catheter ruptured.Access was obtained in the posterior tibial artery and the balloon was inflated using a cook inflation device through a cook 4 french, 5.5 centimeter radial sheath over a cook hydro st wire, inside of an unknown stent.A 70/30 mixture of contrast to omnipaque 360 saline was used to inflate the balloon for ten seconds.The balloon ruptured at eight atmospheres upon the first inflation.It is unknown if the balloon ruptured longitudinally or circumferentially.It is also unknown if blood was noted in the inflation device.The balloon was removed by itself.There was no report of vessel tortuosity; however, moderate calcification was noted.The patient is reportedly "okay".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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Investigation ¿ evaluation.Reviews of the complaint history, device history record, documentation, drawing, instructions for use (ifu), quality control procedures, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the balloon had ruptured longitudinally in the balloon material.No other damage was found on the device.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 drawings and quality control procedures were conducted, and no gaps were discovered.Moreover, an ifu is provided with the device, which includes warnings against exceeding the rated burst pressure and to use an inflation device equipped with a pressure gauge to monitor the inflation pressures.The event description states that the nominal pressure was used when the rupture occurred.Additionally, the intended use of the device is outlined as being 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.There is no indication for post-stent dilatation, for which this device was used.Based on the information provided and the examination of the returned product, investigation has concluded that this event could be traced to intentional off-label usage.Reportedly, the complaint procedure of a post-stent dilatation is outside of the intended scope for the device and for which it is not tested.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Measures are being conducted to address this failure mode.Per the quality engineering risk assessment no further action is required.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: 8796698
• Report Number: 1820334-2019-01708
• Device Sequence Number: 2540084
• Product Code: LIT
• UDI-Device Identifier: 10827002309552
• UDI-Public: (01)10827002309552(17)220410(10)9658341
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2019

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: 04/10/2022
• Device Model Number: G30955
• Device Catalogue Number: PTA4-18-150-5-12
• Device Lot Number: 9658341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Initial Date Received by Manufacturer: 07/05/2019
• Supplement Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 07/16/2019
• Supplement Report FDA Received Date: 08/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR