MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CROSSER 14S (OTW)

Catalog Number CRUO14SA

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported that the recanalization catheter became very hot to the touch.Reportedly, the catheter was activated for approximately 2.5 minutes when the user indicated that it felt hot to the touch.The recanalization catheter was retracted without incident.There was no pt injury.

Manufacturer Narrative

A further clinical review of this event was performed and identified the event to be mdr reportable pursuant to 21 cfr part 803.A manufacturing review could not be conducted as the lot number is unk.The investigation is inconclusive as the device was not returned.The definitive root cause could not be determined based upon the available info.It is unk if pt and/or procedural issues contributed to this event.The current ifu (instructions for use) states: warnings and precautions: do not activate the crosser recanalization system without proper irrigation.Make sure to establish proper irrigation prior to introduction into guide catheter.Always use refrigerated saline.Do not exceed 5 minutes of activation time as crosser catheter malfunction may occur.If 5 minutes of activation time is achieved, exchange for a second crosser catheter before resetting the crosser generator.When manipulating the crosser catheter, the catheter shaft may become warm to the touch.A warm feeling is normal, however, if the catheter shaft becomes hot, discontinue use immediately and withdraw from pt.Once removed from the pt, confirm that irrigation is flowing.

• Brand Name: CROSSER 14S (OTW)
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; tempe AZ
• Manufacturer (Section G): FLOWCARDIA, INC.; 745 n pastoria ave; sunnyvale CA 94085
• Manufacturer Contact: judith ludwig ; 1625 west 3rd st.; tempe, AZ 85281 ; 4808949515
• MDR Report Key: 4810812
• MDR Text Key: 5923450
• Report Number: 2020394-2015-00656
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091119
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/25/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CRUO14SA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1