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

Model Number	G50314
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age: patient was noted to be in her 70s.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 endovascular treatment of the right popliteal artery, an advance 14 lp low profile balloon catheter ruptured.Approach was gained from the right common femoral artery to treat the severely calcified lesion in the right popliteal artery.An unknown short sheath was inserted via antegrade approach, and the lesion was dilated with the device after advancing a 0.014" wire guide through the lesion.During inflation, the balloon ruptured longitudinally.The balloon was removed, and another balloon was used to complete the procedure.There have been no adverse effects to the patient reported.Additional information regarding event details has been requested, but is not available at this time.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.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 27mar2020.The lesion was 99% occluded.The device was inflated, using an unknown inflation device, one time to sixteen atmospheres for ten seconds.The balloon was removed by itself.The patient was "in her 70's".
Additional Manufacturer Narrative
Additional information: d10, h3.The device will not be returned to cook for investigation.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
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Initial report: as reported, during an endovascular treatment of the right popliteal artery, an advance 14 lp low profile balloon catheter ruptured.Approach was gained from the right common femoral artery to treat the severely calcified lesion in the right popliteal artery.An unknown short sheath was inserted via antegrade approach, and the lesion was dilated with the device after advancing a 0.014" wire guide through the lesion.During inflation, the balloon ruptured longitudinally.The balloon was removed, and another balloon was used to complete the procedure.There have been no adverse effects to the patient reported.Investigation ¿ evaluation: reviews of the complaint history, device history record, drawing, instructions for use (ifu), manufacturer¿s instructions, quality control procedures, and specifications of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.The evidence indicates the product was made to specifications.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.No gaps were discovered in the manufacturing instructions, specifications, drawing, or quality control procedures for this device.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.An ifu is provided with this device which warns ¿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¿do not use a power injector for balloon inflation.Rupture may occur.¿ the ifu goes on to note ¿if resistance is encountered while advancing the balloon dilatation catheter, determine the cause and proceed with caution¿inflate balloon to desired pressure.Adhere to recommended balloon inflation pressures.If balloon pressure is lost and / or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit." cook has concluded that the patient¿s anatomy contributed to this incident.It was reported that the lesion was a severely calcified and 99% occluded.The information provided upon review of complaint file, device history record, complaint history, device master record, and design validation testing provide objective evidence to support that the device was manufactured to specification.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.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.
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 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: 9871874
• Report Number: 1820334-2020-00668
• Device Sequence Number: 560744
• Product Code: LIT
• UDI-Device Identifier: 10827002503141
• UDI-Public: (01)10827002503141(17)220606(10)9791680
• Combination Product (Y/N): N
• PMA/510(K) Number: K170193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/22/2020

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: 06/06/2022
• Device Model Number: G50314
• Device Catalogue Number: PTAX4-14-170-2-4
• Device Lot Number: 9791680
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/17/2020
• Supplement Date Received by Manufacturer: 03/27/2020; 05/11/2020; 07/14/2020
• Initial Report FDA Received Date: 03/24/2020
• Supplement Report FDA Received Date: 04/01/2020; 05/13/2020; 07/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TERUMO RADIFOCUS INTRODUCER