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

Model Number	3243
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the packaging seal was torn.A 2.15mm rotapro was selected for use.During preparation, it was found that the packaging seal was torn.There were no patient complications reported.
Event or Problem Description
It was reported that the packaging seal was torn.A 2.15mm rotapro was selected for use.During preparation, it was found that the packaging seal was torn.There were no patient complications reported.It was further reported that the external packaging seal was torn.
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).E1: initial reporter state: (b)(6).
Event or Problem Description
It was reported that the packaging seal was torn.A 2.15mm rotapro was selected for use.During preparation, it was found that the packaging seal was torn.There were no patient complications reported.It was further reported that the external packaging seal was torn.
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).E1: initial reporter state: (b)(6).Device eval by manufacturer: returned product consisted of the rotapro atherectomy system inside the shelf box.The shelf box, closure strip, and product pouch were visually examined.Inspection of the device revealed that the closure strip on the top of the shelf box was peeled back from the shelf box and not secure.The closure strip was also noticed to have been bunched at the end near the arrow.There was evidence of wear marks to the left of the closure strip on the box, which indicates that there was a tight fit and the boxes were rubbing up against each other during either transportation or storage.Product analysis confirmed the reported event, as the top closure strip was peeled back and not adhered to the shelf box.

• Brand Name: ROTAPRO
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10809662
• Report Number: 2134265-2020-15533
• Device Sequence Number: 3525512
• Product Code: MCX
• UDI-Device Identifier: 08714729893394
• UDI-Public: 08714729893394
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P900056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/04/2020

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: 07/22/2022
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0025754572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020
• Initial Date Received by Manufacturer: 10/21/2020
• Supplement Date Received by Manufacturer: 11/11/2020; 12/02/2020
• Initial Report FDA Received Date: 11/09/2020
• Supplement Report FDA Received Date: 11/30/2020; 12/04/2020
• Patient Sequence Number: 1