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

Model Number	G50319
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant products = joker pv 0.014¿ / (b)(6) lifeline, parent 6fr 98cm / medikit, coyote 2-22- / boston scientific.Pma/510(k) number = k170193.This report includes information known at this time.A follow-up report will be submitted at the conclusion of the investigation or, when additional relevant information becomes available.
Event or Problem Description
It was reported, a (b)(6) female was undergoing an endovascular therapy procedure in which a advance 14 lp low profile balloon catheter ruptured upon the second inflation at sixteen atmospheres (atm).Approach was gained from the left brachial artery to treat the calcified occlusion in the right superficial femoral artery.Tortuosity of the patient's anatomy is unknown.After passing through the lesion with a wire guide, the complaint balloon was advanced over the wire guide and the physician started inflating the balloon.However the balloon ruptured when the inflation pressure reached sixteen atm.It is not known if the balloon ruptured circumferentially or longitudinally.It is also not known if there was blood noticed in the inflation device.Type of contrast is unknown.The balloon was removed from the patient's anatomy without the sheath and another manufacturer's balloon was used to successfully completed the procedure.The patient did not experience any adverse effect as a result of this event.
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: a review of the complaint history, drawings, device history record, instructions for use (ifu), manufacturing instructions, specifications, quality control, visual inspection and functional testing of the returned device was conducted during the investigation.The functional inspection of the returned device confirmed that the balloon had a pinhole leak at the distal marker band.The device is also provided with instructions for use which states as a warning, "do not exceed rated burst pressure.1 rupture of balloon may occur.Adhere to balloon inflation pressure parameters in the compliance card insert.Over-inflation may cause rupture of the balloon, with resultant damage to the vessel wall.Use of a pressure gauge is recommended to monitor inflation pressures." 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 be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer's instructions and quality control procedures were conducted, and no gaps were discovered.Based on the information provided and the examination of the returned product, investigation has concluded the cause of this event cannot be traced to the device.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.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.

• Brand Name: ADVANCE 14 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: 8536927
• Report Number: 1820334-2019-00881
• Device Sequence Number: 373664
• Product Code: LIT
• UDI-Device Identifier: 10827002503196
• UDI-Public: (01)10827002503196(17)210626(10)8977004
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2019

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: 06/26/2021
• Device Model Number: G50319
• Device Catalogue Number: PTAX4-14-170-2-20
• Device Lot Number: 8977004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2019
• Initial Date Received by Manufacturer: 04/09/2019
• Supplement Date Received by Manufacturer: 05/02/2019
• Initial Report FDA Received Date: 04/22/2019
• Supplement Report FDA Received Date: 05/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR