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

Model Number	G50336
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2022
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
As reported, the hub of an advance 14 lp low profile balloon catheter "snapped off" upon removal of the device from the patient.The patient's anatomy was reportedly calcified, and another manufacturer's balloon and catheter also broke during the procedure.The case was described as "tricky".The physician clamped the wire port to free the balloon from calcium, and nothing was left in the patient.There has been no report of any adverse effects to the patient.
Event or Problem Description
Upon evaluation of the device on 22jun2022, catheter material remained in the hub.
Additional Manufacturer Narrative
H3: device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.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
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
Additional information was received 15aug2022.The procedure was a peripheral angiogram, and the 90% occluded lesion was located within the superficial femoral artery.A 6 french ansel sheath was used during the procedure.The patient's anatomy was reportedly terribly calcified, and "multiple" balloons from unknown manufacturers also became stuck within the calcium.The balloon was inflated once to an unknown pressure, using a syringe, and allowed to return to ambient pressure once deflated.The device was removed by pulling it over the wire, while maintaining negative pressure.A counterclockwise rotation of the balloon catheter was not conducted upon removal.Blood was not noted in the inflation device, and the balloon was not inflated inside of a stent.After the hub separated, a snare was used to successfully remove the separated portion of the device from the patient.The procedure was completed.The patient did not require any additional procedures or experience any adverse effects due to the occurrence.
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 a peripheral angiogram involving a 90% occluded lesion of the superficial femoral artery, the hub of an advance 14 lp low profile balloon catheter "snapped off" upon removal of the device from the patient.The patient's anatomy was reportedly calcified; multiple balloons became stuck within the calcification, and another manufacturer's balloon and catheter also broke during the procedure.The case was described as "tricky".The balloon was inflated once to an unknown pressure, using a syringe, and allowed to return to ambient pressure once deflated.The device was removed by pulling it over the wire, while maintaining negative pressure.A counterclockwise rotation of the balloon catheter was not conducted upon removal.Blood was not noted in the inflation device, and the balloon was not inflated inside of a stent.After the hub separated, a snare was used to successfully remove the separated portion of the device from the patient.The procedure was completed.The patient did not require any additional procedures or experience any adverse effects due to the occurrence.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.A visual inspection of the returned complaint device was also conducted.The complaint device was returned to cook for investigation.The device was separated at the proximal fitting and had a jagged/rough appearance.Upon disassembling the strain relief from the hub, some of the outer liner was inside the hub.The distal portion of the catheter was elongated/twisted approximately 2 centimeters in length.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other related complaints associated with the complaint device lot.Because there were no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in the field.The instructions for use (ifu) provides the following information to the user related to the reported failure mode: balloon deflation and withdrawal ¿if resistance is encountered during withdrawal, apply negative pressure with a larger syringe before proceeding.If resistance continues, remove balloon and sheath as a until.¿ the information provided upon review of the dmr, dhr, ifu, and investigation of the returned device provides evidence the device was manufactured to specification.Based on the available information and results of the investigation, cook has concluded that patient anatomy contributed to this incident.The lesion being treated was reportedly 90% occluded and the anatomy was extensively calcified.The procedure was described as ¿tricky¿ and another manufacturer¿s balloon catheter also broke during the procedure.The appropriate personnel have been notified and cook will continue to monitor for similar events.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
• 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: 14428599
• Report Number: 1820334-2022-00732
• Device Sequence Number: 17518508
• Product Code: LIT
• UDI-Device Identifier: 10827002503363
• UDI-Public: (01)10827002503363(17)250317(10)14605232
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K170193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/14/2022

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: 03/17/2025
• Device Model Number: G50336
• Device Catalogue Number: PTAX4-14-170-4-6
• Device Lot Number: 14605232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/04/2022
• Supplement Date Received by Manufacturer: 06/22/2022; 08/15/2022; 09/23/2022
• Initial Report FDA Received Date: 05/18/2022
• Supplement Report FDA Received Date: 07/05/2022; 09/14/2022; 10/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SHOCKWAVE BALLOON, UNKNOWN CATHETER.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown