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

Catalog Number CRE14S

Device Problems Material Separation (1562); Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 05/30/2014

Event Type  malfunction  

Event Description

It was reported that prior to patient use, the catheter did not vibrate and warm up.Another catheter was used to perform the procedure.There was no patient involvement.

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 was conducted.The lot met all release criteria.The device was returned for evaluation.The outer catheter appeared to be bunching and partially separated from the distal tip.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 title, and was able to penetrate the tile with no issues.Upon removal from the plaster tile, the outer catheter separated from the distal tip.The investigation is confirmed for material separation based upon the condition in which the sample was returned.The investigation is unconfirmed for device inoperable, as the device was able to successfully vibrate and mist during functional testing.The root cause could not be determined based upon available information.As another catheter was used without issue with the same generator, it is unknown if procedural issues contributed to the event.Section a through d- the information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

• Brand Name: CROSSER 14S (RX)
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; tempe AZ
• Manufacturer (Section G): C.R. BARD INC. (GFO); 289 bay road; queensbury NY 12804 204
• Manufacturer Contact: judith ludwig ; 1625 west 3rd st.; tempe, AZ 85281 ; 4808949515
• MDR Report Key: 4811524
• MDR Text Key: 5916176
• Report Number: 2020394-2015-00813
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K072776
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/26/2014

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: Other
• Device Expiration Date: 12/31/2015
• Device Catalogue Number: CRE14S
• Device Lot Number: GFXL0241
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/05/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2013
• 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