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

Model Number	N/A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This event is currently under investigation.
Event or Problem Description
It was reported that an advance 14 lp low profile balloon catheter device was used for a plain old balloon angioplasty (poba) to treat chronic total occlusion (cto) in the anterior tibial artery (ata) but it ruptured at the first attempt of inflation due to calcification.Therefore, it was replaced with a short 14lp (3-2) and the procedure was completed successfully.The direction of the rupture cannot be determined as the device will not be returned.There have been no adverse effects to the patient reported.
Additional Manufacturer Narrative
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.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.According to the information provided by the reporter, it is plausible to suggest that this incident was human anatomy-related.Based on the information provided, no product returned, and the results of our investigation; a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.
Event or Problem Description
It was reported that an advance 14 lp low profile balloon catheter device was used for a plain old balloon angioplasty (poba) to treat chronic total occlusion (cto) in the anterior tibial artery (ata) but it ruptured at the first attempt of inflation due to calcification.Therefore, it was replaced with a short 14lp (3-2) and the procedure was completed successfully.The direction of the rupture cannot be determined as the device will not be returned.There have been no adverse effects to the patient reported.

• 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: 6633238
• Report Number: 1820334-2017-01420
• Device Sequence Number: 13576984
• Product Code: DQY
• UDI-Device Identifier: 10827002503332
• UDI-Public: (01)10827002503332(17)180904(10)6180348
• 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: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2017

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 Model Number: N/A
• Device Catalogue Number: PTAX4-14-170-3-20
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/15/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/12/2017
• Supplement Report FDA Received Date: 06/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1