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

Catalog Number	PTAX4-14-170-3-4
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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, an (b)(6) male was undergoing a left leg run off procedure of the peroneal trunk when, upon initial insertion, an advance 14 lp low profile balloon catheter ruptured circumferentially.The rupture occurred during the first inflation at 10 atmospheres (atm).Another manufacturer's inflation device was used.Visipaque contrast to saline was used in a one to one ratio.The vessel was highly calcified but only slightly angulated.After the rupture, the advance 14 lp low profile balloon catheter was removed through a sheath.The procedure was successfully completed with another balloon of the same type.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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
A review of the complaint history, device history record, drawing, instructions for use (ifu), manufactures instructions, quality control, and a functional test & visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that the device was returned with biomatter present on the inside and outside of the device.This suggests the balloon was in fact used.It also initially suggests that part of the balloon lumen of the device had communicated with the patient¿s vasculature.This was confirmed with functional testing of the balloon as a pinhole balloon rupture was discovered near the proximal bond.No other notable damage was found on 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 no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Furthermore, a review of the manufactures instructions, drawing, and quality control procedures was conducted, and no gaps were discovered.Moreover, an ifu is provided with this device, which states ¿use a 1:1 mixture of contrast medium and saline.It states that a 0.014 wire guide is compatible with the catheter.¿ it goes on to stay to ¿not exceed the rated burst pressure.¿ the pressure used exceeds the nominal pressure but does not match or exceed the rated burst pressure.The diameter of the wire guide is not known and therefore cannot be spoken to.User error is not believed to be associated with the alleged failure of this device.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be established.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.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.

• 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: 8126274
• Report Number: 1820334-2018-03505
• Device Sequence Number: 19262888
• Product Code: DQY
• UDI-Device Identifier: 10827002503288
• UDI-Public: (01)10827002503288(17)211025(10)9261460
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2019

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: 10/25/2021
• Device Catalogue Number: PTAX4-14-170-3-4
• Device Lot Number: 9261460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2018
• Initial Date Received by Manufacturer: 11/20/2018
• Supplement Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 12/03/2018
• Supplement Report FDA Received Date: 03/04/2019
• 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: 6 FR ANSEL SHEATH, ABBOTT INDEFLATOR
• Patient Age: 80 YR
• Patient Weight: 104