MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER RAPID EXCHANGE; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	M00545820
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	07/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a tandem rx cannula was used during a procedure performed on (b)(4) 2017.According to the complainant, during unpacking, a foreign object was found sticking to the green guide wire introducer port.The procedure was completed with another tandem rx cannula.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be unknown.
Additional Manufacturer Narrative
A visual evaluation of the returned device found that the device was returned outside of its original package; a small piece of foreign matter was found at the guide wire port section of the returned device.No other issue was noted.The investigation concluded that it is very difficult to know if the foreign matter was present before or after the unit was originally packaged during the manufacturing process.Therefore taking into consideration all the information available and the condition of the returned product, a definitive root cause could not be identified and the most probable root cause of this event will be documented as ¿undeterminable¿.A dhr (device history record) review was performed and no deviation was found.A search of the complaint database revealed that no similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that a tandem rx cannula was used during a procedure performed on (b)(6) 2017.According to the complainant, during unpacking, a foreign object was found sticking to the green guide wire introducer port.The procedure was completed with another tandem rx cannula.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be unknown.

• Brand Name: RAPID EXCHANGE
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 6743651
• Report Number: 3005099803-2017-02244
• Device Sequence Number: 10925924
• Product Code: GCJ
• UDI-Device Identifier: 08714729301905
• UDI-Public: (01)08714729301905(17)20190331(10)20347797
• Combination Product (Y/N): N
• PMA/510(K) Number: K970054
• 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): 07/05/2017

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: 03/31/2019
• Device Model Number: M00545820
• Device Catalogue Number: 4582
• Device Lot Number: 20347797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2017
• Initial Date Received by Manufacturer: 07/05/2017
• Supplement Date Received by Manufacturer: 07/26/2017
• Initial Report FDA Received Date: 07/26/2017
• Supplement Report FDA Received Date: 08/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1