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

Model Number G30958

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

Patient Problems Foreign Body In Patient (2687); No Code Available (3191)

Event Date 01/09/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant devices: cook sphere inflation device,.014" csi viper wire.Pma/510(k) number = k130293.(b)(4).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported, during the initial inflation inside the patient's anatomy, the advance 18 lp low profile balloon catheter ruptured circumferentially prior to reaching nominal pressure.Inflation pressure was reported as approximately 7 atmospheres(atm).Reportedly, the male patient was undergoing peripheral angioplasty of a lesion in the distal to mid superficial femoral artery.Access was obtained in the left common femoral artery treating the right leg.The patient's anatomy was calcified but not angulated.Mixture of contrast to saline is unknown but the fluid was still in place inside the complaint device at the time of rupture.Subsequently, the physician attempted to back the complaint device out of the patient's anatomy through the sheath; however, it became stuck on the guide wire.A clockwise rotation was not used during removal.Both the wire and complaint device were then removed together.During removal, a portion of the complaint device broke off and remained inside the patient's anatomy.Unsuccessful attempts were made to remove this portion using "a wire, catheter, suction and snares".The retained portion was surgically removed on (b)(6) 2019.Reportedly, the patient is doing fine.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.A review of the dimensional verification, quality control, complaint history, device history, documentation, instructions for use, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the distal portion of the balloon and shaft had separated, as they were not returned, and the distal marker band was not found.A circumferential tear on the balloon material was found, as well as a longitudinal tear extending from the distal point of separation.Separation of the device is considered a cascading event from the rupture.Additionally, a document-based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Furthermore, a review of quality control procedures was conducted, and no gaps were discovered.Moreover, instructions for use (ifu) are provided with this device.The ifu includes warnings against exceeding the rated burst pressure and to use an inflation device equipped with a pressure gauge to monitor the inflation pressures.If balloon pressure is lost and/or a balloon rupture occurs, the balloon is to be deflated and removed with the sheath as a unit.It is noted that the removal of the balloon and sheath as a unit was not followed and may have contributed to the separation of the device.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be established.Measures are being conducted to address this failure mode.We will continue our monitoring of similar complaints and have 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 BALLOON CATHETER
• Type of Device: LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8253275
• MDR Text Key: 133239330
• Report Number: 1820334-2019-00138
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 10827002309583
• UDI-Public: (01)10827002309583(17)210905(10)9138775
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/05/2021
• Device Model Number: G30958
• Device Catalogue Number: PTA4-18-150-5-20
• Device Lot Number: 9138775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Date Manufacturer Received: 03/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention