MAUDE Adverse Event Report: COOK INC ADVANCE 35 LP LOW PROFILE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Model Number	G52280
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 a peripheral angioplasty procedure two advance 35 lp low profile balloon catheter devices ruptured.According to the initial reporter, the ruptures occurred on the back table, during prep, and the devices never made patient contact.It was reported that the balloons were inflated using a mix of 2cc of contrast with 8 cc of saline.It was stated that both of the balloons burst at 2-3 atms.It is unknown which direction the ruptures occurred.Additionally, a similar device was used to successfully complete the procedure.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.See the manufacturer report number 1820334-2018-03230 for the second balloon.This report is for the first balloon.
Event or Problem Description
Please see h10 for additional information.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information additional information was received noting the balloon did make patient contact.Per contact at user facility: "i remember it was inside the vessel as he was re-prepping the balloon so he does it [inflates the device] before entering the body and inside".No section of the device remained in the patient and the patient did not require additional procedures as a result of the event.The procedure was completed successfully and the result was patency of the vessels.Patient pre-existing conditions were also provided.These included non-pressure chronic ulcer of left heel and midfoot with necrosis of muscle.Unspecified atherosclerosis of nonautologous biological bypass graft(s) of the extremities, a left leg peripheral vascular angioplasty status with implants and grafts.Hyperlipidemia essential (primary) hypertension.Bilateral primary osteoarthritis of hip.Hyperlipidemia, unspecified chronic viral hepatitis c.Along with hypothyroidism, unspecified atherosclerosis of native arteries of the left leg with ulceration of part of the foot.Finally, non-pressure chronic ulcer of other part of unspecified foot with necrosis of muscle back on 4/30/2018.Investigation ¿ evaluation a review of the dimensional verification, complaint history, device history record, documentation, drawing, instructions for use (ifu), manufactures instructions, quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the balloon had ruptured.The device was returned in its original packaging.Upon initial investigation, biomatter could be seen on the hub and throughout the balloon on both the inside and outside.The catheter and tip were free of damage with both marker bands present and secure.This information was inconsistent with the originally reported event.After reaching out to the facility, investigation was able to confirm additional information noting a rupture inside the patient, as opposed to on the prepping table.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 one nonconforming event which could contribute to this failure mode.This device was marked as nonconforming because of a leak noted during quality inspection.The affected unit was scrapped prior to order completion.It should also be noted there were no other reported complaints for this lot number.Furthermore, an ifu is provided with the device.This ifu addresses instruction for balloon preparation and introduction.In preparation, the steps outline the process of preparing the balloon lumen and purge the system of air bubbles.During introduction of the catheter, negative pressure should be applied.This is to be held until the balloon has been advanced to the lesion site.At this point, inside the patient, the balloon shall be inflated.Moreover, a review of the manufactures instructions, quality control procedures, and design history was conducted and revealed no gaps.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.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 35 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: 8072241
• Report Number: 1820334-2018-03229
• Device Sequence Number: 2279252
• Product Code: DQY
• UDI-Device Identifier: 10827002522807
• UDI-Public: (01)10827002522807(17)210508(10)8869644
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K091527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/08/2021
• Device Model Number: G52280
• Device Catalogue Number: PTA5-35-135-8-6.0
• Device Lot Number: 8869644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2018
• Initial Date Received by Manufacturer: 10/18/2018
• Supplement Date Received by Manufacturer: 12/20/2018
• Initial Report FDA Received Date: 11/14/2018
• Supplement Report FDA Received Date: 01/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 56