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

Model Number	N/A
Medical Device Problem Codes	Break (1069); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Initial reporter occupation- lead scrub 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.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
It was reported, that during an arteriogram with intervention, an advance 18 lp low profile balloon catheter ruptured.The lesion was at the approximately fifty percent occluded superficial femoral artery.The patient's anatomy was not tortuous or calcified and the balloon was not believed to have been inflated inside of a stent prior to the rupture.An unspecified 5 french cook sheath was utilized.During the procedure, the balloon was inflated with an inflation device three to four times for a duration of thirty to forty five seconds each time.There was blood noted on the inflation device.Once deflated, the balloon was able to return to ambient pressure and negative pressure was maintained.The sheath, balloon unit, and wire were attempted to be removed as a unit without counterclockwise rotation when the tip of the catheter came off.All parts of the devices were able to be removed from the patient when they removed the sheath and wire.The procedure was believed to be completed, however access was lost due the event and they were unable to confirm with imaging.As reported, the patient did not experience any adverse effects, have any unintended section of the device remain inside the patient's body or require any additional procedures due to this occurrence.
Event or Problem Description
Additional information received 17mar2023.The pressure rate is unknown, but it was not taken to "burst pressure".The device was not taken out and put back in the patient.
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
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Summary of event: as reported, during an arteriogram with intervention, an advance 18 lp low profile balloon catheter ruptured.The lesion was in the approximately fifty percent occluded superficial femoral artery.The patient's anatomy was not tortuous or calcified and the balloon was not believed to have been inflated inside of a stent prior to the rupture.An unspecified 5 french cook sheath was utilized.During the procedure, the balloon was inflated with an inflation device three to four times for a duration of thirty to forty-five seconds each time.There was blood noted on the inflation device.Once deflated, the balloon was able to return to ambient pressure and negative pressure was maintained.The sheath, balloon unit, and wire were attempted to be removed as a unit, without counterclockwise rotation, when the tip of the catheter came off.All parts of the devices were able to be removed from the patient when they removed the sheath and wire.The procedure was believed to be completed; however, access was lost due the event and they were unable to confirm with imaging.As reported, the patient did not experience any adverse effects, have any unintended section of the device remain inside the patient's body, or require any additional procedures due to this occurrence.Additional information was received 17mar2023.The pressure rate is unknown, but it was not taken to "burst pressure".The device was not taken out and put back in the patient.Investigation evaluation: reviews of the complaint history, device history record, 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.No related non-conformances were found, and there have been no other reported complaints for this lot number.The product ifu states ¿if balloon pressure is lost and/or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit.¿ 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.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the information provided and the results of the investigation, cook has concluded that a component failure contributed to this event.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.

• 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: 16547002
• Report Number: 1820334-2023-00261
• Device Sequence Number: 6521046
• Product Code: LIT
• UDI-Device Identifier: 10827002309644
• UDI-Public: (01)10827002309644(17)251114(10)15067345
• 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): 07/19/2023

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: 11/14/2025
• Device Model Number: N/A
• Device Catalogue Number: PTA4-18-150-6-20
• Device Lot Number: 15067345
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/09/2023
• Supplement Date Received by Manufacturer: 03/17/2023; 06/23/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 03/24/2023; 07/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2022
• 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
• Patient Sex: Female