MAUDE Adverse Event Report: BRIDGEPOINT MEDICAL, INC. A SUBSIDIARY OF BSC CROSSBOSS; CATHETER, PERCUTANEOUS

Catalog Number M-2000

Device Problems Kinked (1339); Out-Of-Box Failure (2311); Failure to Advance (2524)

Patient Problem No Information (3190)

Event Date 01/10/2014

Event Type  malfunction  

Event Description

Catheter was kinked at distal end of catheter; discovered upon opening package.One attempt to load on the wire failed.The wire did not pass through the lumen at the location of the kink.The catheter was put to the side and another cross boss was opened.The box upon inspection did not appear damaged.Small procedure delay for patient.
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manufacturer response for cross boss catheter, (brand not provided) (per site reporter).
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provided new device.

• Brand Name: CROSSBOSS
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BRIDGEPOINT MEDICAL, INC. A SUBSIDIARY OF BSC; two scimed place; maple grove MN 55311
• MDR Report Key: 3638694
• MDR Text Key: 4208609
• Report Number: 3638694
• Device Sequence Number: 1
• Product Code: LOX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 02/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: M-2000
• Device Lot Number: 8132130144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2014
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/17/2014
• Event Location: Hospital
• Date Report to Manufacturer: 02/21/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR