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

Catalog Number CRE14S

Device Problem Difficult To Position (1467)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/25/2014

Event Type  Injury  

Event Description

It was reported that after the recanalization catheter had been activated for 1 minute and 27 seconds in the sfa, the catheter and the guidewire advanced into the subintimal layer.The tip of the guidewire prolapsed and detached, remaining in the false lumen of the artery.The recanalization catheter was removed without incident and a stent was implanted in the vessel, opposing the guidewire tip to the wall.There was no reported pt injury.

Manufacturer Narrative

A further clinical review of this event was performed and identified the event to be mdr reportable as a serious injury pursuant to 21 cfr part 803.A mfg review was conducted.The lot met all released criteria.This is the only complaint reported to date for corporate lot number gfxj0877, for the issue.The investigation is inconclusive, as the sample was not returned for eval.Per the ifu, after advancing the guidewire and crosser catheter to the lesion site.The guidewire needs to be withdrawn approximately 1cm within the catheter so that the tip of the crosser catheter is the leading edge.It is likely that the user did not withdraw the guidewire into the distal tip of the crosser catheter prior to activating the crosser.Having the guidewire fully advanced through the distal tip of the crosser catheter during activation could cause the guidewire to break.Therefore, the root cause is most likely user related.The crosser catheter instructions for use (ifu) provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device.

• Brand Name: CROSSER 14S(RX)
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; tempe AZ
• Manufacturer (Section G): CR BARD INC (GFO); 289 bay rd; queensbury NY 12804 204
• Manufacturer Contact: brett curtice ; 1625 west 3rd st.; tempe, AZ 85281 ; 4808949515
• MDR Report Key: 4810660
• MDR Text Key: 21468276
• Report Number: 2020394-2015-00783
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/04/2014

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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2015
• Device Catalogue Number: CRE14S
• Device Lot Number: GFXJ0877
• 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
• Date Device Manufactured: 10/01/2013
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR