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

Model Number 39467-150

Device Problems Device Contaminated During Manufacture or Shipping (2969); Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event is an estimated date based off the aware date as the exact event date was not reported.

Event Description

It was reported that foreign matter was present.A 1.50mm rotapro was selected for use.Upon opening the sterile pouch, the packaging was damaged and a black plastic piece was found floating within the packaging.Another of the same device was used to complete the procedure.No patient complications were reported.

Event Description

It was reported that foreign matter was present.A 1.50mm rotapro was selected for use.Upon opening the sterile pouch, the packaging was damaged and a black plastic piece was found floating within the packaging.Another of the same device was used to complete the procedure.No patient complications were reported.

Manufacturer Narrative

Date of event is an estimated date based off the aware date as the exact event date was not reported.Device evaluated by mfr: the rotapro atherectomy system was received with the shelf box, opened product pouch, and alleged black foreign material (fm) in a small ziploc bag.Media was attached to the complaint showing the foreign material within the packaging.The advancer, handshake connections, housing, sheath, coil, and burr were visually examined.Inspection of the device did not reveal any damages or defects.The returned pouch was inspected, and there were no damages or defects identified.In order to classify the returned foreign material, it was inspected using an ftir which identified abs [acrylonitrile-butadiene-styrene].Review performed found that this material is used in the knob, tube extension, and the brake button.Inspection of those components did not identify any damages attributable to the foreign material located within the pouch.Product analysis confirmed the reported event, as the returned foreign material matched the foreign material in the attached media.Analysis was not able to identify the origin of the foreign material.The reported damaged packaging was not able to be confirmed, as there was no damages or defects identified to the packaging.

• Brand Name: ROTAPRO
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road cork; cork IRELA ND; EI IRELAND
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12044262
• MDR Text Key: 257725943
• Report Number: 2134265-2021-07928
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 8714729893356
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/06/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 12/16/2022
• Device Model Number: 39467-150
• Device Catalogue Number: 39467-150
• Device Lot Number: 0026528457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2021
• Initial Date FDA Received: 06/22/2021
• Supplement Dates Manufacturer Received: 12/02/2021
• Supplement Dates FDA Received: 12/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1