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

Model Number G30859

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

Patient Problem Foreign Body In Patient (2687)

Event Date 03/23/2021

Event Type  Injury  

Manufacturer Narrative

Reporter occupation = radiology tech.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.

Event Description

As reported, during an interventional procedure involving the right superficial femoral artery, an advance 18 lp low profile pta balloon dilatation catheter ruptured circumferentially and separated in the patient upon removal of the device.The balloon was inflated with 5.2 milliliters of contrast and twelve milliliters of saline, using a cook inflation device.The balloon ruptured prior to reaching nominal pressure.Negative pressure was maintained upon withdrawal of the catheter; however, a counterclockwise rotation of the catheter was not conducted.The anatomy was not tortuous or angulated, but was reportedly highly calcified.The tip of the device remained in the patient, as an attempt to remove the balloon was unsuccessful.The patient had received heparin during the procedure; therefore, additional attempts to retrieve the balloon were not made, and the patient was hospitalized.An ultrasound was performed, and the physician confirmed the presence of a pulse in the leg via doppler.A follow-up procedure will be scheduled to remove the separated portion of the device.Upon return and initial evaluation of the device, the tip of the catheter material was also found to have separated from the device.During the same procedure, a pin hole was found in another advance 18 lp low profile pta balloon dilation catheter.This has been reported under patient identifier 326755.

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 Description

Additional information was received 21apr2021: the patient has continued to do well and no follow-up procedure has been needed.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary: as reported, during an interventional procedure involving the right superficial femoral artery, an advance 18 lp low profile pta balloon dilatation catheter ruptured circumferentially and separated in the patient upon removal of the device.The balloon was inflated with 5.2 milliliters of contrast and twelve milliliters of saline, using a cook inflation device.The balloon ruptured prior to reaching nominal pressure.Negative pressure was maintained upon withdrawal of the catheter; however, a counterclockwise rotation of the catheter was not conducted.The anatomy was not tortuous or angulated but was reportedly highly calcified.The tip of the device remained in the patient, as an attempt to remove the balloon was unsuccessful.The patient had received heparin during the procedure; therefore, additional attempts to retrieve the balloon were not made, and the patient was hospitalized.An ultrasound was performed, and the physician confirmed the presence of a pulse in the leg via doppler.The patient has continued to do well, and no follow-up procedure has been needed.Investigation - evaluation.Reviews of the complaint history, device history record, drawing, instructions for use, quality control procedures, and specifications and a visual inspection of the device were conducted during the investigation.One advance 18 lp low profile pta balloon dilatation catheter was returned for investigation.Bio matter was present on the device.It was found that the balloon was ruptured circumferentially.Only 10.2cm of the proximal section of balloon was present on the catheter.One gold marker band was present at the proximal end.The distal tip was not returned.A document-based investigation evaluation was performed.No related nonconformances were recorded, and there have been no other lot-related complaints received.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.No gaps were discovered during reviews of the device manufacturing instructions or quality control procedures.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The instructions for use provided with the device state the following: balloon preparation ¿choose a balloon appropriate to lesion length and vessel diameter.¿ ¿upon removal from package, inspect the catheter to ensure no damage has occurred during shipping.¿ balloon introduction and inflation ¿note: if resistance is met while advancing the balloon dilatation catheter, determine the cause and proceed with caution.¿ ¿inflate balloon to desired pressure.Adhere to recommended balloon inflation pressures.(see compliance card insert.)¿ ¿if balloon pressure is lost and/or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit.¿ balloon deflation 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 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 the patient¿s anatomy and the procedure contributed to this incident.As reported, severe calcification of the lesion was present during the procedure, and it is known that a counter-clockwise rotation was not performed upon removal of the ruptured balloon.These contributing factors likely led to the failure mode in this 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.

Event 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 PTA BALLOON DILATATION CATHETER
• Type of Device: LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11609922
• MDR Text Key: 245591872
• Report Number: 1820334-2021-01061
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 10827002308593
• UDI-Public: (01)10827002308593(17)231215(10)13630234
• Combination Product (y/n): N
• PMA/PMN Number: K130293
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2023
• Device Model Number: G30859
• Device Catalogue Number: PTAX4-18-170-6-20
• Device Lot Number: 13630234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Date Manufacturer Received: 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BARD HALO SHEATH 4-5FR
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR