MAUDE Adverse Event Report: COOK INC ADVANCE 18 LP LOW PROFILE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Catalog Number	PTA4-18-135-7-4
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported, during an arteriovenous fistula case, the advance 18 lp low profile balloon catheter "burst".According to the initial reporter, the complaint device balloon was inflated above rated burst pressure, to approximately 19-20 bar when it ruptured.Following the rupture, the balloon broke into pieces and these portions were removed from the patient's vessel with a snare.Additional information regarding event details, patient anatomy and outcome has been requested, but is not available at this time.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, or unavailable, or unchanged.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available and/or when the investigation is completed.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
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Event or Problem Description
Additional information regarding the patient and/or event has been received since the previous medwatch report was sent.This information is detailed in section.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, or unavailable, or unchanged.Additional information was received from the customer regarding the reported incident.The customer confirmed that, when dilating the balloon to open a lesion, the device was inflated several times at different locations.The inflation pressure used was reconfirmed to be 19-20 bar.The vessel was reportedly not calcified at all, and there was no angulation present; the lesion was only fibrotic in nature.The balloon burst circumferentially, and parts of the balloon reportedly remained inside the patient's left vein.The radiopaque marker was still attached to the balloon parts, so they could be snared.The customer needed to put two covered stents in the patient's left cephalic vein, where the lesion was reportedly located.The procedure took more than 4 hours instead of the planned procedure time of approximately 60 minutes.Additionally, the customer reported that omnipack contrast was used, but the ratio of contrast to saline was not reported.A 6 french merit introducer was utilized in conjunction with the device, and a wire guide was placed during the attempted removal.Once deflated, the balloon was allowed to return to ambient pressure prior to removal.Upon the withdrawal of the balloon catheter, a clockwise rotation of the balloon was not conducted.Other relevant history: diabetes.Investigation ¿ evaluation a review of the dimensional verification, complaint history, device history record, documentation, instructions for use (ifu), quality control, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the device was separated in four separate pieces.Segment 1 includes the proximal hub, catheter, and the proximal end of the balloon material.There were two pieces, segment 2 and 3, which were of the clear catheter shaft normally found beneath the balloon material.This material was elongated, and had sections appearing like an accordion.The forth segment contained the distal tip and balloon material.The balloon material had folded over the distal tip.Both marker bands were contained in the 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 be noted there were no other reported complaints for this lot number.The device is shipped with an ifu which indicated that the intended use of the catheter is for percutaneous transluminal angioplasty of lesions, including those obstructing native or synthetic arteriovenous dialysis fistulae.The document includes a warning to not exceed the rated burst pressure, as rupture may occur.Upon removal from the packaging, the product is to be inspected for damage.The ifu also recommends the use of a pressure gauge during inflation to monitor the pressure.Additionally, a 1:1, saline to contrast mixture is directed to be used as the inflation medium.Based on the information provided, the examination of the returned product, and the results of our investigation, the root cause was traced to the user; the user of the device did not follow the instructions for the usage of the device.We will continue to monitor for similar complaints.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
• Common Device Name: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8080916
• Report Number: 1820334-2018-03300
• Device Sequence Number: 18885947
• Product Code: DQY
• UDI-Device Identifier: 10827002502571
• UDI-Public: (01)10827002502571(17)200623(10)8014185
• Combination Product (Y/N): N
• Initial Reporter Country: SE
• PMA/510(K) Number: K073378
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/23/2020
• Device Catalogue Number: PTA4-18-135-7-4
• Device Lot Number: 8014185
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/25/2018
• Supplement Date Received by Manufacturer: 11/18/2018; 11/18/2018
• Initial Report FDA Received Date: 11/16/2018
• Supplement Report FDA Received Date: 11/19/2018; 12/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention