MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CROSSBOSS; CATHETER, PERCUTANEOUS

Model Number 1466-03

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/08/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the seal was broken.A crossboss was selected for use.Upon preparation, it was noted that the seal was broken, and the sterility was compromised.The procedure was completed with a different device.No complications reported and patient was stable post procedure.

Manufacturer Narrative

E1.Initial reporter facility name: (b)(6) hospital.Device evaluated by manufacturer.The device was returned for analysis.Returned product consisted of a crossboss micro-catheter in the carrier tube.The packaging for this compliant device was not returned for analysis.The hub, torque device, shaft, and tip were visually inspected.There was no damage or irregularities to the device.Product analysis could not confirm the reported event, as the packaging for the device was not returned so it was unable to confirm if the seal was opened and compromised.

Event Description

It was reported that the seal was broken.A crossboss was selected for use.Upon preparation, it was noted that the seal was broken, and the sterility was compromised.The procedure was completed with a different device.No complications reported and patient was stable post procedure.

• Brand Name: CROSSBOSS
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10212846
• MDR Text Key: 196975934
• Report Number: 2134265-2020-08644
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/16/2020
• Device Model Number: 1466-03
• Device Catalogue Number: 1466-03
• Device Lot Number: 0023527207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Date Manufacturer Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 58