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

Catalog Number	PTA5-35-80-7-4.0
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	10/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
It was reported that during a dialysis access fistulogram procedure, the advance 35 lp low profile balloon catheter ruptured circumferentially while at an inflation pressure of less than or equal to 12, and then separated prior to removal.The advance 35 lp low profile balloon catheter was able to be completely removed from inside of the patient.An additional procedure was completed to place another manufacturer's stent as there was a rupture in the patient's left basilic vein.It is unknown if the complaint device caused or contributed to the ruptured vein.A section of the device did not remain inside the patient¿s body.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 complaint history, drawings, dimensional verification, device history record, instructions for use (ifu), manufacturing instructions, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.One used advance 35 lp low profile balloon catheter was returned for examination.The distal marker band is present; the proximal marker band is not present.The distal section of catheter tubing is elongated.The catheter and balloon are separated into two sections.The total length of catheter is outside the upper specification limit.Balloon burst longitudinally and radially.The total length of the balloon is within specification.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record showed three non-conformances; however, all non-conforming product was scrapped or re-worked as appropriate, prior to completion of the final lot.In addition, there were no other reported complaints for this lot number.Based on the information provided, examination of the returned product, and the results of our investigation; a definitive root cause could not be determined.However, measures have been initiated to address this failure mode.The appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• 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: 6982296
• Report Number: 1820334-2017-03733
• Device Sequence Number: 488187
• Product Code: DQY
• UDI-Device Identifier: 10827002523521
• UDI-Public: (01)10827002523521(17)191026(10)7388385
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: PTA5-35-80-7-4.0
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/25/2017
• Supplement Date Received by Manufacturer: 02/08/2018
• Initial Report FDA Received Date: 10/26/2017
• Supplement Report FDA Received Date: 02/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR