MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COMET; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number	8900
Medical Device Problem Codes	Contamination (1120); Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that a comet dropped on the floor.During preparation and while outside the patient, a comet pressure guidewire was being removed from the packaging, but dropped on the floor.It was noted that the internal plastic sheet on the opposite side of the planned opening strap of the comet packaging was removed, but the interlayer suddenly tore off into two parts and the comet pressure guidewire dropped on the floor.The procedure was completed with another of the same device.No patient complications were reported in relation to this event.
Event or Problem Description
It was reported that a comet dropped on the floor.During preparation and while outside the patient, a comet pressure guidewire was being removed from the packaging, but dropped on the floor.It was noted that the internal plastic sheet on the opposite side of the planned opening strap of the comet packaging was removed, but the interlayer suddenly tore off into two parts and the comet pressure guidewire dropped on the floor.The procedure was completed with another of the same device.No patient complications were reported in relation to this event.
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Evaluation by mfr: the original packaging was returned to boston scientific for analysis.No device was returned.The returned packaging was examined for damage or any irregularities.The packaging showed it was opened incorrectly.The packaging was not opened at the recommended area, it was opened upside down on the opposite end of the sterile barrier opening.Inspection of the remainder of the packaging, apart from the observed damage, revealed no other damage or irregularities.The complaint was confirmed for packaging issues.

• Brand Name: COMET
• Common Device Name: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10596647
• Report Number: 2134265-2020-13291
• Device Sequence Number: 1151986
• Product Code: DXO
• UDI-Device Identifier: 08714729904397
• UDI-Public: 08714729904397
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K151610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2020

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: 03/16/2022
• Device Model Number: 8900
• Device Catalogue Number: 8900
• Device Lot Number: 0025362296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2020
• Initial Date Received by Manufacturer: 09/03/2020
• Supplement Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 09/28/2020
• Supplement Report FDA Received Date: 11/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1