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

Model Number G30949

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

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

Event Date 12/03/2019

Event Type  Injury  

Manufacturer Narrative

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

As reported, during an unspecified procedure of the popliteal artery involving a patient with a history of peripheral artery disease, an advance 18 lp low profile balloon catheter ruptured circumferentially and separated.A 6 french cook ansel sheath was used and an unknown inflation device was used to inflate the balloon one time using omnipaque contrast, to approximately six atmospheres, when the balloon ruptured and separated.Reportedly, a pre-dilation with another manufacturer's balloon occurred prior to using the complaint device.The anatomy was reported to be heavily calcified, and the above-the-knee popliteal lesion was approximately 99% occluded.Tortuosity was not reported.The device was not inflated inside a stent prior to rupture.The distal end of the balloon remained in the patient, as the physician was unable to remove it.The physician stented the balloon in place.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Investigation ¿ evaluation.Reviews of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturer¿s instructions, quality control procedures, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed one used pta4-18-150-4-12 was returned to cook for investigation.Physical examination of the returned device confirmed that the balloon ruptured circumferentially and separated.Biomatter was present on the device.The catheter was received in two pieces, and the remainder of balloon and the distal tip of the catheter was not returned.The proximal segment consists of the strain relief, batwing fitting, and 8mm of catheter shaft.The distal segment consists of 137.7cm of catheter shaft and 5.2cm of balloon material.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 also be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions, drawing, specifications, and quality control procedures were conducted, and no gaps were discovered.Moreover, an ifu is provided with the device, which warns ¿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.¿ the ifu continues, ¿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 information provided and the examination of the returned product, investigation has concluded that this event could not be traced to the device but t the patient¿s anatomy.Reportedly, the patient's anatomy was heavily calcified, and the above-the-knee popliteal lesion was approximately 99% occluded.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Measure are being taken to address this failure mode.Per the quality engineering risk assessment no further action is required.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.

• 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: 9437629
• MDR Text Key: 170643832
• Report Number: 1820334-2019-03041
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 10827002309491
• UDI-Public: (01)10827002309491(17)210717(10)9022392
• 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: 01/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/17/2021
• Device Model Number: G30949
• Device Catalogue Number: PTA4-18-150-4-12
• Device Lot Number: 9022392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Date Manufacturer Received: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STERLING 2MM BALLOON
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 73 YR