MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. SEEKER CROSSING SUPPORT CATHETER

Catalog Number SK13535

Device Problems Peeled/Delaminated (1454); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 03/11/2013

Event Type  malfunction  

Event Description

It was reported that after the crossing support catheter was removed from mid sfa without incident, the catheter had a gelatinous-like substance on it.Another crossing support catheter was used to complete the procedure.There was no pt injury.

Manufacturer Narrative

After further clinical review of this event with bard's medical dept, this event was reassessed and determined to be mdr reportable as a malfunction pursuant to 21 cfr part 803.The lot number for the device has been provided.A review of the device history records is currently being performed.The device has been returned to the manufacturer for eval.The investigation is currently underway.

Manufacturer Narrative

The lot number has been provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.The device was returned.The catheter was returned slightly discolored with the hydrophilic coating peeling from the catheter.The coating was brittle and crumbled when touched.A kink was identified in the catheter approximately 11cm from the distal tip.No foreign material was identified on the catheter, it should be noted that all seeker catheter undergo 100% inspections to ensure proper cure on the hydrophilic coating, 100% of catheter od are measured at incoming inspection, and seeker catheter lubricity and coating length are tested for an acceptable sample size.Based on the results of the investigation, it is likely that the gelatinous material reported by the user was the coating that peeled from the catheter.It is unknown how or when the coating was damaged.This is the (b)(4) complaint to date for this device and failure mode.Based on the available information, the definitive root cause is unknown.The seeker 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: SEEKER CROSSING SUPPORT CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; tempe AZ
• Manufacturer (Section G): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd st.; tempe AZ 85281
• Manufacturer Contact: catherine burkhardt ; 1625 west 3rd st.; tempe, AZ 85281 ; 4808949515
• MDR Report Key: 4810825
• MDR Text Key: 5923452
• Report Number: 2020394-2015-00721
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/12/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2013
• Device Catalogue Number: SK13535
• Device Lot Number: VTWD1275
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/22/2013
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2015
• Initial Date FDA Received: 05/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/06/2015
• 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