MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTALINK BURR; CATHETER, CORONARY, ATHERECTOMY

Model Number	3320
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/28/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the sterility was compromised as the inner package of the device was damaged.The target lesion was located in a coronary artery.A 2.00mm rotalink burr was selected for use.During unpacking, it was noted that the sterility was compromised as the inner package of the device was damaged.The procedure was completed with another of the same device.No patient complications were reported and the patient was stable post procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.A rota burr catheter was received for analysis without any packaging.Microscopic and visual inspection did not reveal any damage.
Event or Problem Description
It was reported that the sterility was compromised as the inner package of the device was damaged.The target lesion was located in a coronary artery.A 2.00mm rotalink burr was selected for use.During unpacking, it was noted that the sterility was compromised as the inner package of the device was damaged.The procedure was completed with another of the same device.No patient complications were reported and the patient was stable post procedure.

• Brand Name: ROTALINK BURR
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9439444
• Report Number: 2134265-2019-15275
• Device Sequence Number: 14127418
• Product Code: MCX
• UDI-Device Identifier: 08714729126881
• UDI-Public: 08714729126881
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P900056
• 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): 02/11/2020

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: 12/09/2019
• Device Model Number: 3320
• Device Catalogue Number: 3320
• Device Lot Number: 0021580173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Initial Date Received by Manufacturer: 11/28/2019
• Supplement Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 12/09/2019
• Supplement Report FDA Received Date: 02/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 60