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 Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported that during a lower extremity intervention using an advance 14 low profile balloon catheter, the tech realized that the hub separated from the main body of the catheter.It was reported that this occurred prior to the second insertion of the balloon catheter, when the inflation device was attached to the hub.
Additional Manufacturer Narrative
Additional information received indicated that the procedure performed was an angioplasty and stent.The access was gained via contralateral approach and there was a lesion was located in the tibia.The patient also had medical history significant for angulation and vessel calcification/tortuosity.The technician also reported that the device was being used a second time.Investigation - evaluation: a review of documentation, device history record, drawing, manufacturing instructions, specifications, quality control data and visual inspection of the returned device was conducted during the investigation.One used advance 14lp low profile balloon catheter was returned for investigation.The strain relief was intact and attached to the catheter.The hub was separated from the strain relief catheter at the neck of the hub.The fractured portion inside the strain relief was 1.0 cm.The hub was fractured 2 mm below the neck.A document based investigation evaluation was also performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.Based upon the information provided and the characteristics displayed, it is plausible to suggest that this incident was technique related and/or human anatomy related.Per the quality engineering risk assessment no further action is required.Monitoring for similar complaints will continue.

• 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: 6590288
• Report Number: 1820334-2017-01008
• Device Sequence Number: 13711374
• Product Code: DQY
• UDI-Device Identifier: 10827002503332
• UDI-Public: (01)10827002503332(17)200317(10)7758284
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2017

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?: Yes
• Initial Date Received by Manufacturer: 04/27/2017
• Supplement Date Received by Manufacturer: 07/07/2017
• Initial Report FDA Received Date: 05/25/2017
• Supplement Report FDA Received Date: 07/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1