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

Catalog Number	PTA4-18-150-7-4
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, during an angiogram, an advance 18 lp low profile balloon catheter's balloon ruptured.The anatomy was tortuous and highly calcified.The balloon catheter was advanced through an unspecified cook 6-french, 45-centimeter ansel sheath.Another manufacturer's inflation device was used to inflate the balloon one time to fourteen atmospheres, within a 70% occluded lesion in the left common femoral artery, at which point the balloon ruptured circumferentially.Blood was noted within the inflation device at the time of rupture.The balloon was not inflated within a stent.Upon attempted removal of the balloon, it wrapped around the sheath and the devices became stuck in the patient's groin.The patient was taken to surgery, and an open surgical procedure was performed to remove the balloon catheter and sheath.The patient is reportedly doing well.There has been no alleged malfunction of the cook sheath.Additional information has been requested.
Additional Manufacturer Narrative
E3: occupation = lead tech.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 on 05oct2023.The cook sheath used during the procedure did not malfunction in any way.The balloon ruptured circumferentially and the balloon material partially separated; however, the balloon material remained attached to the catheter shaft.A counterclockwise rotation of the device was not conducted upon attempted removal.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during an angiogram, an advance 18 lp low profile balloon catheter's balloon ruptured.The anatomy was tortuous and highly calcified.The balloon catheter was advanced through an unspecified cook 6-french, 45-centimeter ansel sheath.Another manufacturer's inflation device was used to inflate the balloon one time to fourteen atmospheres, within a 70% occluded lesion in the left common femoral artery, at which point the balloon ruptured circumferentially.Blood was noted within the inflation device at the time of rupture.The balloon was not inflated within a stent.Upon attempted removal of the balloon, it wrapped around the sheath and the devices became stuck in the patient's groin.The patient was taken to surgery, and an open surgical procedure was performed to remove the balloon catheter and sheath.The patient is reportedly doing well.There has been no alleged malfunction of the cook sheath.Additional information was received 05oct2023.The cook sheath used during the procedure did not malfunction in any way.The balloon ruptured circumferentially, and the balloon material partially separated; however, the balloon material remained attached to the catheter shaft.A counterclockwise rotation of the device was not conducted upon attempted removal.Investigation evaluation: reviews of the complaint history, device history record (dhr), drawing, instructions for use (ifu), and quality control procedures were conducted during the investigation.The complaint device was not returned to cook for investigation.A document-based investigation evaluation was performed.A review of the device history record found no relevant non-conformances on the lot.A review of complaint history found no additional complaints for this lot number.The product ifu states ¿particular care should be taken in handling the balloon to prevent damage.¿ the ifu warns ¿do not exceed rated burst pressure.Rupture of balloon may occur.Adhere to balloon inflation pressure parameters in the compliance card insert.¿ the ifu instructs the user to remove the balloon and sheath as a unit if rupture occurs.Regarding deflation and withdrawal of the device, the ifu states ¿completely deflate the balloon using an inflation device or syringe.Maintain vacuum on the balloon and withdrawal the catheter.Upon catheter withdrawal, a gentle counterclockwise rotation of the catheter will assist balloon rewrap, minimizing trauma to the percutaneous entry site.If resistance is met during withdrawal, apply negative pressure with a larger syringe before proceeding.If resistance continues, remove balloon and sheath as a unit.¿ a review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The information provided upon review of the dmr, dhr, and ifu suggests that there is evidence the device was manufactured to specification.There is no evidence of non-conforming devices in-house or in the field.Based on the information provided and the results of the investigation, cook has concluded that the patient¿s highly calcified and tortuous anatomy contributed to this event, as the balloon was inflated to the rated burst pressure within a 70% occluded lesion.The risk analysis for this failure mode was reviewed and no additional escalation 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 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
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 17865105
• Report Number: 1820334-2023-01331
• Device Sequence Number: 5705139
• Product Code: LIT
• UDI-Device Identifier: 10827002343396
• UDI-Public: (01)10827002343396(17)260312(10)15270943
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K130293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/12/2026
• Device Catalogue Number: PTA4-18-150-7-4
• Device Lot Number: 15270943
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2023
• Supplement Date Received by Manufacturer: 10/05/2023; 02/14/2024
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 10/13/2023; 02/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BOSTON SCIENTIFIC INFLATION DEVICE; COOK 6X45 ANSEL SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male