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

Model Number	G50333
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant products: 4fr sheath, cook hydro st.014 wire, cook inflation device.Occupation: lead 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
It was reported during an angioplasty procedure of a right occluded posterior tibial vessel, the advance 14 lp low profile balloon catheter ruptured.According to the initial reporter, the balloon device was inserted into a 4fr sheath via pedal access then advanced to the posterior tibial vessel.Upon inflating the device using a 70/30 contrast to saline solution, the balloon ruptured at 8 atmospheres.The user removed the ruptured balloon and used a 3x4 balloon to finish the procedure.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 information has been requested, but is not available at this time.
Event or Problem Description
Additional information was received 21apr2020.The balloon was inflated for four seconds prior to rupture.The patient's anatomy was calcified.The balloon was removed over the wire guide.Blood was noted in the inflation device upon rupture.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: b5, d10, d11.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: it was reported during an angioplasty procedure of a right occluded posterior tibial vessel, the advance 14 lp low profile balloon catheter ruptured.According to the initial reporter, the balloon device was inserted into a 4fr sheath via pedal access then advanced to the posterior tibial vessel.Upon inflating the device using a 70/30 contrast to saline solution, the balloon ruptured at 8 atmospheres.The user removed the ruptured balloon and used a 3x4 balloon to finish the procedure.Additional information was received 21apr2020.The balloon was inflated for four seconds prior to rupture.The patient's anatomy was calcified.The balloon was removed over the wire guide.Blood was noted in the inflation device upon rupture.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.Investigation evaluation: a review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, specifications, and a functional test and visual inspection of the complaint device was conducted during the investigation.Physical examination of the returned complaint device noted biomatter throughout the balloon.A leak test was performed using air, and a pinhole leak was found at the distal end of the balloon.A document review was completed as a response to this event.A device master record review was performed, including device specifications, drawings, manufacturing instructions, and quality control procedures.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The device's design history files were reviewed and showed that for the testing related to this failure, all test samples met the acceptance criteria.No related non-conformances were found, and there have been no other reported complaints for this lot number.The complaint file, device history record, complaint history, validations, and manufacturing documents provide evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.The product ifu instructs the user to inspect the device for damage upon removal from the package.The ifu states: ¿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." the ifu warns the user against over-inflation and states that rupture may occur.Based on the information provided and the results of the investigation, cook has concluded that a definitive conclusion could not be determined.The risk analysis for this failure mode was reviewed and no action was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.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 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: 9959336
• Report Number: 1820334-2020-00814
• Device Sequence Number: 2808120
• Product Code: LIT
• UDI-Device Identifier: 10827002503332
• UDI-Public: (01)10827002503332(17)230120(10)10275652
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K170193
• 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,Followup
• Report Date (Section B): 07/21/2020

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: 01/20/2023
• Device Model Number: G50333
• Device Catalogue Number: PTAX4-14-170-3-20
• Device Lot Number: 10275652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2020
• Initial Date Received by Manufacturer: 04/09/2020
• Supplement Date Received by Manufacturer: 04/21/2020; 07/14/2020
• Initial Report FDA Received Date: 04/14/2020
• Supplement Report FDA Received Date: 06/05/2020; 07/21/2020
• 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: COOK 4 FR RADIAL SHEATH
• Patient Age: 61 YR