MAUDE Adverse Event Report: COOK INC ADVANCE 14 LP LOW PROFILE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Catalog Number	PTAX4-14-170-2.5-12
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, or unavailable.(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 an endovascular therapy procedure via the femoral approach, the balloon of the advance 14 lp low profile balloon catheter ruptured.Per the initial reporter, when the balloon reached the severely calcified lesion, it was inflated to 10 atmospheres (atm).Approximately 100 seconds after the start of inflation the rupture occurred.It is not known if the balloon ruptured longitudinally or circumferentially.Contrast used was visipaque in a 1:1 ration with saline.The procedure was successfully completed with another balloon device.The patient did not require any additional procedures due to this occurrence.No adverse events were reported.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the dimensional verification, complaint history, device history record, drawing, instructions for use (ifu), quality control, specifications, and a visual inspection and functional evaluation of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed the presence of a pinhole, which was noted in the balloon a distance of 11.4 cm from the distal end of the catheter.No other non-conformities were noted during the evaluation.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.We will continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is required.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.Refer to additional mfr narrative for investigational findings.

• Brand Name: ADVANCE 14 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: 7430299
• Report Number: 1820334-2018-00733
• Device Sequence Number: 2156207
• Product Code: DQY
• UDI-Device Identifier: 10827002503240
• UDI-Public: (01)10827002503240(17)190329(10)6849703
• Combination Product (Y/N): N
• PMA/510(K) Number: K090822
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2018

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: PTAX4-14-170-2.5-12
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/28/2018
• Supplement Date Received by Manufacturer: 07/18/2018
• Initial Report FDA Received Date: 04/13/2018
• Supplement Report FDA Received Date: 07/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1