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

Catalog Number	PTAX4-14-170-3-20
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported, the advance 14 lp low profile balloon catheter burst during a "right leg runoff" procedure.Access was gained at the left groin.Upon reaching the target site, heavy calcification was noted.The device was inflated to 3-4 atmospheres of pressure when it ruptured.Another device was used to complete the procedure.Additional information for the sheath used during the procedure was requested, but could not be confirmed at this time.A section of the device did not remain inside the patient¿s body.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.
Additional Manufacturer Narrative
Investigation ¿ evaluation.A review of the dimensional verification, complaint history, device history record, instructions for use (ifu), manufacturing instructions, quality control, and a visual inspection and functional evaluation of the returned device were conducted during the investigation.The visual inspection of the returned device following inflation confirmed that the "rupture" reported by the customer was a pinhole leak.The leak was positioned slightly proximal to the proximal marker band.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 that 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.

• 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: 7710545
• Report Number: 1820334-2018-02271
• Device Sequence Number: 18997267
• Product Code: DQY
• UDI-Device Identifier: 10827002503332
• UDI-Public: (01)10827002503332(17)210524(10)8905883
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K090822
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2018

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 Expiration Date: 05/24/2021
• Device Catalogue Number: PTAX4-14-170-3-20
• Device Lot Number: 8905883
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 07/23/2018
• Supplement Report FDA Received Date: 08/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR