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

Model Number	G50324
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a below-the-knee intervention an advance 14 lp low profile balloon catheter was inflated to nominal pressure when it ruptured.Another balloon was used to complete the procedure.No portion of the device was left within the patient.There was no need for additional procedures or prolonged hospitalization.No adverse effects to the patient occurred due to this event.
Additional Manufacturer Narrative
This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
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
Additional information was received 20dec2021.An unspecified inflation device and a 50/50 ratio of omnipaque contrast to saline were used to inflate the device to eight atmospheres one time for two minutes.The balloon ruptured longitudinally upon the first inflation within a lesion in the anterior tibial artery, which was reportedly 100% occluded.The vessel was also heavily calcified.The balloon was removed by itself and another manufacturer's sheath was kept in place.Blood was not noted in the inflation device and the balloon was not inflated within a stent prior to rupturing.
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
Event summary: as reported, during a below-the-knee intervention an advance 14 lp low profile balloon catheter ruptured.An unspecified inflation device and a 50/50 ratio of omnipaque contrast to saline were used to inflate the device to eight atmospheres one time for two minutes.The balloon ruptured longitudinally upon the first inflation within a lesion in the anterior tibial artery, which was reportedly 100% occluded.The vessel was also heavily calcified.The balloon was removed by itself and another manufacturer's sheath was kept in place.Blood was not noted in the inflation device and the balloon was not inflated within a stent prior to rupturing.Another balloon was used to complete the procedure.No portion of the device was left within the patient.There was no need for additional procedures or prolonged hospitalization.No adverse effects to the patient occurred due to this event.Investigation - evaluation: reviews of the complaint history, device history record, drawing, specifications, instructions for use, manufacturing instructions, and quality control procedures of the device were conducted during the investigation.No device was returned for investigation.A document-based investigation evaluation was performed.Two relevant nonconformances were recorded; all affected product was scrapped, and the lot is inspected 100%.There have been no other reported complaints for this lot number.The device history record review provides objective 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.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is provided with instructions for use which warn, ¿do not exceed rated burst pressure.Rupture of balloon may occur.Adhere to balloon inflation pressure parameters in the compliance card insert.Over-inflation may cause rupture of the balloon, which resultant damage to the vessel wall.Use of a pressure gauge is recommended to monitor inflation pressures,¿ and, ¿do not use a power injector for balloon inflation.Rupture may occur.¿ based on the available information, cook has concluded that the patient¿s anatomy, which was reported to be heavily calcified and totally occluded within the access site vessel, is the likely cause of the reported incident.Cook will continue monitoring of similar complaints and has 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 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 ; 8128294891
• MDR Report Key: 12950931
• Report Number: 1820334-2021-02640
• Device Sequence Number: 4860331
• Product Code: LIT
• UDI-Device Identifier: 10827002503240
• UDI-Public: (01)10827002503240(17)231007(10)13476950
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K170193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2022

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: 10/07/2023
• Device Model Number: G50324
• Device Catalogue Number: PTAX4-14-170-2.5-12
• Device Lot Number: 13476950
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2021
• Supplement Date Received by Manufacturer: 12/20/2021; 03/09/2022
• Initial Report FDA Received Date: 12/07/2021
• Supplement Report FDA Received Date: 12/20/2021; 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2020
• 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: CORDIS 5 FRENCH SHEATH.
• Patient Sex: Male