MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CROSSER S6

Catalog Number CRUS6A

Device Problems Melted (1385); Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2013

Event Type  malfunction  

Event Description

It was reported that the recanalization catheter tip melted during use on the pt.The length of activation was approximately 5 minutes.During retraction of the recanalization catheter through the support catheter, the recanalization catheter became lodged in the support catheter.Both the recanalization catheter and support catheter had to be removed as a single unit.Upon withdrawal, the two devices were separated and it was found that the recanalization catheter was melted.The support catheter reportedly had a flattened area on it as well.Another recanalization catheter and support catheter were used to complete the procedure.No report of injury to the pt.

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 mfg review was conducted.The lot met all release criteria.The catheter and support catheter were returned.The investigation is confirmed for retraction issues as the catheter could not be removed from the support catheter.The investigation is inconclusive for melting due to poor sample condition (i.E.The catheter could not be fully examined as it could not be removed from the support catheter).However, no evidence of melting was present on the visible exterior of either device.Per the complaint comments, the activation was approximately 5 minutes.Per the ifu, the activation time should not exceed 5 minutes.As it is unk if the activation time exceeded 5 minutes, it is possible this contributed to the reported failure.However, the definitive root cause could not be determined based upon the available info.It is unk if pt and/or procedural issues contributed to the reported event.

• Brand Name: CROSSER S6
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; tempe AZ
• Manufacturer (Section G): FLOWCARDIA, INC.; 745 north pastoria avenue; sunnyvale CA 94085
• Manufacturer Contact: bret heinrich ; 1625 west 3rd st.; tempe, AZ 85281 ; 4808949515
• MDR Report Key: 4810831
• MDR Text Key: 16187823
• Report Number: 2020394-2015-00666
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092175
• 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: 04/17/2013

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 Expiration Date: 11/30/2014
• Device Catalogue Number: CRUS6A
• Device Lot Number: FCWL10001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/01/2013
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2012
• 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