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

Catalog Number	PTA5-35-80-8-2.0
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/26/2018
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 a left upper extremity fistulogram with possible intervention procedure, the advance 35 lp low profile balloon catheter burst when it was inflated to burst pressure, 11 atmospheres (atm) over an 0.35 wire.Upon removing the complaint device over the wire, the balloon fractured.The patient did not retain any balloon fragments, as it was removed in it's entirety with the sheath.Manual pressure was held and vascular access was obtained again.The procedure continued with a new balloon device, wire and sheath.The procedure was completed successfully.According to the initial reporter, the patient did not require any additional procedures as a result of this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the dimensional verification, complaint history, device history record, drawing, instructions for use (ifu), manufacturing 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 catheter portion was separated into three pieces.Additionally, the proximal balloon section ruptured radially and longitudinally.The distal balloon section ruptured radially.2.1 cm of accordion damage was observed on the middle segment of the device, and the middle segment and distal segment have wire guide through the lumen.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 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.(b)(4).
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 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: 7503193
• Report Number: 1820334-2018-01300
• Device Sequence Number: 1813746
• Product Code: DQY
• UDI-Device Identifier: 10827002523583
• UDI-Public: (01)10827002523583(17)200915(10)8220595
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2018

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 Catalogue Number: PTA5-35-80-8-2.0
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/26/2018
• Supplement Date Received by Manufacturer: 08/01/2018
• Initial Report FDA Received Date: 05/10/2018
• Supplement Report FDA Received Date: 08/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 0.035 WIRE
• Patient Age: 75 YR
• Patient Weight: 79