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

Catalog Number	PTAX4-14-170-2-12
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 that during an unspecified procedure, an advance 14 lp low profile balloon catheter was contralaterally advanced from the common femoral artery (cfa) to the below the knee (bk) lesion.The balloon ruptured as it was attempted to be inflated at the lesion.Another advance 14 lp low profile balloon catheter (refer to medwatch 1820334-2018-00332) was attempted to be utilized to complete the procedure; however, it ruptured as well.Another manufacturer's device was used to successfully complete the procedure.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Additional / corrected information: the two advance 14 lp low profile balloon catheters (longitudinally - unsure) ruptured at nominal pressure.The patient's below the knee (bk) lesion was located in the anterior tibial artery.Vessel calcification was noted at the lesion.This report includes information known at this time. a follow-up report will be submitted should additional relevant information become available.
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.There is no evidence to suggest the finished product was not made to specifications.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 shows no nonconforming events.The sub-assembly lots were also reviewed and two non-conformances were noted; however, all non-conforming product was scrapped or re-worked as appropriate prior to completion of the final lot.There were no other reported complaints for this lot number.It was reported that the balloon was advanced and inflated in a significantly calcified area and it is possible that the reported failure is related to the patient condition.However, based on the information provided, no product returned, and the results of our investigation; a definitive root cause could not be determined.Per the 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: 7221663
• Report Number: 1820334-2018-00331
• Device Sequence Number: 11242227
• Product Code: DQY
• UDI-Device Identifier: 10827002503172
• UDI-Public: (01)10827002503172(17)180109(10)5566893
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K090822
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/05/2018

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: PTAX4-14-170-2-12
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/23/2018
• Supplement Date Received by Manufacturer: 01/25/2018; 02/01/2018
• Initial Report FDA Received Date: 01/26/2018
• Supplement Report FDA Received Date: 01/29/2018; 02/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1