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

Model Number	10592
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Returned product consisted of a crossboss micro-catheter, but there was no indication if the fm (foreign material) was returned for analysis.When analyzed, there was no fm in the bio-hazard bag with the device.The hub, shaft, torque device, and tip were visually and microscopically inspected.Inspection of the device presented no damage or irregularities to the device.The guidewire used in the procedure was not returned for analysis, so a test guidewire was used for functional testing.The test wire was advanced through the shaft of the device with no resistance or issues.When the guidewire was advanced back and forth, a bloody fluid came out of the tip but no fm came out of the shaft.
Event or Problem Description
It was reported that a foreign material was present in the device.The target lesion was located in the totally occluded right coronary artery.A crossboss re-entry device was selected for use.During the procedure inside the patient, several wires were tried to advanced through the crossboss but was unable to advance to the crossboss.The crossboss was then taken out and when flushing was performed, a blue material that was particle of a blue sterile towel flushed out.The procedure was completed with a different device.No patient complications were reported and the patient was fine.
Event or Problem Description
It was reported that a foreign material was present in the device.The target lesion was located in the totally occluded right coronary artery.A crossboss re-entry device was selected for use.During the procedure inside the patient, several wires were tried to advanced through the crossboss but was unable to advance to the crossboss.The crossboss was then taken out and when flushing was performed, a blue material that was particle of a blue sterile towel flushed out.The procedure was completed with a different device.No patient complications were reported and the patient was fine.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Returned product consisted of a crossboss micro-catheter, but there was no indication if the fm (foreign material) was returned for analysis.When analyzed, there was no fm in the bio-hazard bag with the device.The hub, shaft, torque device, and tip were visually and microscopically inspected.Inspection of the device presented no damage or irregularities to the device.The guidewire used in the procedure was not returned for analysis, so a test guidewire was used for functional testing.The test wire was advanced through the shaft of the device with no resistance or issues.When the guidewire was advanced back and forth, a bloody fluid came out of the tip but no fm came out of the shaft.

• Brand Name: CROSSBOSS
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9289884
• Report Number: 2134265-2019-13405
• Device Sequence Number: 13979405
• Product Code: DQY
• UDI-Device Identifier: 08714729837510
• UDI-Public: 08714729837510
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K102725
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/12/2020
• Device Model Number: 10592
• Device Catalogue Number: 10592
• Device Lot Number: 0023239035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Initial Date Received by Manufacturer: 10/15/2019
• Supplement Date Received by Manufacturer: 10/31/2019
• Initial Report FDA Received Date: 11/07/2019
• Supplement Report FDA Received Date: 11/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR