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

Catalog Number	PTAX4-14-110-2.5-8
Medical Device Problem Codes	Deflation Problem (1149); Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/25/2017
Type of Reportable Event	Malfunction
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 an angioplasty, the advance 14 lp low profile balloon catheter deflated, could not hold pressure, and ruptured at 10 atmosphere (atm).During inspection of the balloon at the end of the procedure, it was noted that the balloon was not pierced but a leak was present at the level of the support catheter.The balloon was able to be inflated up to 8 atm; however, a constant pressure of 10 atm was not able to be applied from thirty (30) seconds to one (1) minute as the balloon was deflating.The patient had stenosis prior to the angioplasty procedure.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.The patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), specifications, and quality control was conducted during the investigation.The complaint device was not returned; therefore, no physical examination could be performed.However, a document-based investigation was performed.Numerous design verification and validation activities have been performed to ensure that this device meets design requirement, each balloon is 100% inspected and verified prior to release.A review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.A review of the sub assembly device history record was reviewed and three non-conformances were noted; however; all non-conforming product was not part of the finished lot.There were no other reported complaints for this lot number.The information from the customer suggests there was a leak in the catheter itself.Based upon the information provided and the characteristics displayed, it is plausible to suggest that this incident was user handling related, storage related, other device compatibility, or human anatomy related.However, as no product was returned, and based on the results of our investigation; a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• 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: 7042808
• Report Number: 1820334-2017-04000
• Device Sequence Number: 1332027
• Product Code: DQY
• UDI-Device Identifier: 10827002187983
• UDI-Public: (01)10827002187983(17)200131(10)7636433
• 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: foreign,user facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2018

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: PTAX4-14-110-2.5-8
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/28/2017
• Supplement Date Received by Manufacturer: 01/15/2018
• Initial Report FDA Received Date: 11/17/2017
• Supplement Report FDA Received Date: 01/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1