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

Model Number	G52270
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/06/2017
Type of Reportable Event	Malfunction
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 that during angioplasty of the left superficial femoral artery, the advance 35 lp low profile balloon catheter ruptured at 10 atmospheres (atm) inflation pressure.There was no vessel angulation or calcification.Nonionic contrast with a ratio of 7ml contrast to 3ml 0.9% saline solution was used.Another device was used to successfully complete the procedure.Per the complainant, the patient remained stable through the end of the procedure.According to the initial reporter, a section of the device did not remain inside the patient's body.The patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, documentation, drawing, instructions for use, quality control, and specifications of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, 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 shows 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, no product returned and the results of our investigation, a definitive root cause could not be determined.Measures are being conducted to address this failure mode.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
Additional Manufacturer Narrative
A photograph of the complaint device was returned by the customer, and a photographic evaluation was performed as a part of the complaint investigation.From the photograph, it is difficult to determine if there is a balloon rupture or not.No further information was provided.
Event or Problem Description
Additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 7454715
• Report Number: 1820334-2018-01045
• Device Sequence Number: 11171870
• Product Code: DQY
• UDI-Device Identifier: 10827002522708
• UDI-Public: (01)10827002522708(17)200223(10)7701000
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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): 07/25/2018

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 Model Number: G52270
• Device Catalogue Number: PTA5-35-135-6-14.0
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/09/2018
• Supplement Date Received by Manufacturer: 05/03/2018; 07/16/2018
• Initial Report FDA Received Date: 04/24/2018
• Supplement Report FDA Received Date: 05/18/2018; 07/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR