MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CROSSER RECANALIZATION CATHETER

Catalog Number CRU14SA

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/22/2013

Event Type  malfunction  

Event Description

It was reported that the recanalization catheter became very hot to the touch.Reportedly, the catheter was activated for less than 2 minutes when the user indicated that it felt hot to the touch.The catheter was used to successfully cross a 40cm cto in the sfa.There was no pt injury.

Manufacturer Narrative

H10: 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 investigation lot number is unk.The device was returned for eval and the marker band appeared to be slightly flattened.The catheter between the metal distal tip and marker band was slightly blackened.The device was attached to the transducer of the in-house generator and an in-house flowmate was used to flush the device was saline.The device was able to produce vibrations throughout the entire length of the catheter.Misting was observed coming out from the distal tip, indicating that the device was vibrating properly.The distal tip of the catheter was pressed against one end of a 5mm plaster tile, and was able to penetrate the tile with no issues.No unexpected heat was observed to be emitting from the catheter during testing.The investigation is unconfirmed as no overheating was observed to the catheter during testing.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) outlines warnings and precautions.

• Brand Name: CROSSER RECANALIZATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; tempe AZ 85281
• 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: 4810811
• MDR Text Key: 18384938
• Report Number: 2020394-2015-00654
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072776
• 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: CRU14SA
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/04/2013
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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