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

Model Number G30901

Device Problems Material Rupture (1546); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/24/2022

Event Type  Injury  

Manufacturer Narrative

(b)(6).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, during a percutaneous transluminal angioplasty of the popliteal artery, an advance 18 lp low profile balloon catheter ruptured and separated.After the balloon ruptured, it was unable to be removed from an unknown introducer and subsequently separated, leaving half of the balloon over an unknown wire in the superficial femoral artery (sfa).A bare metal stent was placed in the sfa to hold the fragment in place and prevent migration.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Additional information has been requested.

Event Description

Additional information was received 06jul2022.The patient's anatomy was angulated, tortuous, 85% occluded, and highly calcified.The balloon was inflated once to 10 atm using visipaque 270 contrast before rupturing circumferentially.As the balloon was withdrawn, blood was noted in the inflation device.Negative pressure was maintained during removal, but the balloon was not rotated counterclockwise.

Manufacturer Narrative

Additional information: b5, d10.Event summary as reported, during a percutaneous transluminal angioplasty of the popliteal artery, an advance 18 lp low profile balloon catheter ruptured and separated.The patient's anatomy was angulated, tortuous, 85% occluded, and highly calcified.The balloon was inflated once to 10 atm using visipaque 270 contrast before rupturing circumferentially.As the balloon was withdrawn, blood was noted in the inflation device.Negative pressure was maintained during removal, but the balloon was not rotated counterclockwise.The device was unable to be removed from another manufacturer's introducer and subsequently separated, leaving half of the balloon over an unknown wire in the superficial femoral artery (sfa).A bare metal stent was placed in the sfa to hold the fragment in place and prevent migration.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation - evaluation reviews of the complaint history, device history record, drawing, instructions for use, and quality control procedures of the device were conducted during the investigation.The device was not returned for investigation.A document-based investigation evaluation was performed.No related non-conformances were recorded, and 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 provide the following instructions for balloon inflation and withdrawal: ¿1.Completely deflate the balloon using an inflation device or syringe.Allow adequate time for the balloon to deflate.Note: balloons with large diameters and/or longer lengths may require longer deflation times.2.Deflate the balloon by pulling a vacuum on the inflation syringe or inflation device.Maintain vacuum on the balloon and withdraw the catheter.Upon catheter withdrawal, a gentle counterclockwise rotation of the catheter will assist balloon rewrap, minimizing trauma to the percutaneous entry site.3.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.¿ based on the available information, cook has concluded that patient anatomy likely caused this failure.The patient's anatomy was angulated, tortuous, 85% occluded, and highly calcified.The subsequent separation of the balloon material was likely due to a cascading failure of following instructions when the user attempted to remove the balloon through the sheath.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 18 LP LOW PROFILE BALLOON CATHETER
• Type of Device: 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: 14164086
• MDR Text Key: 289739060
• Report Number: 1820334-2022-00615
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 10827002309019
• UDI-Public: (01)10827002309019(17)240503(10)13934644
• Combination Product (y/n): N
• PMA/PMN Number: K130293
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G30901
• Device Catalogue Number: PTA4-18-80-5-15
• Device Lot Number: 13934644
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CORDIS 5FR SHEATH
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 50 KG