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

Model Number	G30964
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) number: k130293.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, a (b)(6) male was undergoing an intervention of the left superficial femoral artery from the right groin.The patient's vasculature was described as severely calcified but not tortuous or angled.The physician inflated the advance 18 lp low profile balloon catheter for 30 seconds and deflated once using a 70/30 mixture of omnipaque 350 contrast to saline.The physician moved the complaint balloon to an unspecified area and attempted a second inflation.It was noted the balloon would not fully inflate.Inflation pressure was reported to be 8 atmospheres (atm).The physician deflated the balloon and noticed blood in the cook inflation device.It was subsequently determined the balloon ruptured and it was removed through the ansel sheath.Another manufacturer's.018 guide wire was over the balloon.The patient was not harmed and did not require any additional intervention.No portion of the balloon remained in the patient's anatomy.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, or unavailable.Investigation - evaluation a review of the complaint history, drawings, device history record, functional testing, instructions for use (ifu), manufacturing instructions, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.Return of the used complaint device confirms a leak near the proximal bond.The device is also provided with instructions for use which includes information regarding ruptures.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.Based on the information provided, the examination of the returned product, and the results of our investigation, a cause for this event could not be established.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 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.

• Brand Name: ADVANCE 18 LP LOW PROFILE BALLOON CATHETER
• Common Device Name: LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8358149
• Report Number: 1820334-2019-00449
• Device Sequence Number: 2229828
• Product Code: LIT
• UDI-Device Identifier: 10827002309644
• UDI-Public: (01)10827002309644(17)191128(10)7470782
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2019

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: 11/28/2019
• Device Model Number: G30964
• Device Catalogue Number: PTA4-18-150-6-20
• Device Lot Number: 7470782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2019
• Initial Date Received by Manufacturer: 02/12/2019
• Supplement Date Received by Manufacturer: 04/24/2019
• Initial Report FDA Received Date: 02/21/2019
• Supplement Report FDA Received Date: 05/02/2019
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 93