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

Model Number	G52272
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Materials coordinator.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, the advance 35 lp low profile balloon catheter ruptured in an arteriovenous fistula procedure.Upon reaching the target site in the arm, the device was inflated to 17 atmospheres of pressure, with a "50/50 mix" of contrast and saline, when it ruptured.The rupture was circumferential, making it difficult to retrieve from the sheath, as stated by the initial reporter.There was no angulation, although calcification was noted.The device was removed, and the procedure was completed.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
Correction: operator of device: this was inadvertently marked 'ni' when our complaint form did indicate a physician using the device.This field has been updated to 'health professional'.Investigation/evaluation: a review of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufactures instructions, quality control, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the balloon had ruptured circumferentially; however, it was also noted that the balloon rupture longitudinally as well.Shaft damage was present and attributed to the device being used and having trouble to remove the device.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 three nonconformances that were found during the manufacturing process on three devices.One of these is related to balloon leakage from the distal bond of the balloon.Neither this nonconformance, nor the others are believed to be associated with the failure mode as all devices were scrapped and did not present with circumferential ruptures.It should be noted there were no other reported complaints for this lot number.Furthermore, the during the device failure analysis, due to the balloon material showing evidence of both a longitudinal and circumferential rupture, it could not be functionally tested.However, both marker bands were present, but were not secure and were moving freely.Moreover, the catheter shaft was elongated between the two balloon bonds.A compression and kink of the catheter shaft was found proximal to the balloon.There appears to be no lost material from the balloon catheter.Confirming that no section(s) of the device remained inside the patient.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.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or 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 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: 7774025
• Report Number: 1820334-2018-02427
• Device Sequence Number: 16397055
• Product Code: DQY
• UDI-Device Identifier: 10827002522722
• UDI-Public: (01)10827002522722(17)200406(10)7808619
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2018

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: 04/06/2020
• Device Model Number: G52272
• Device Catalogue Number: PTA5-35-135-7-4.0
• Device Lot Number: 7808619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 08/10/2018
• Supplement Report FDA Received Date: 10/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1