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

Model Number	M00545820
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a rapid exchange was unpacked for an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during preparation outside the patient, package of rapid exchange was opened and when device was taken out from the sheath, there was dirt-like foreign object found on the tip part of the catheter.The procedure was completed with a second tandem rx cannula.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6 (device codes): problem code 2944 captures the reportable event of foreign material present in the device.Block h10: the returned rx cannula was analyzed, and a visual evaluation noted that a foreign particle was inside the plastic bag where the unit was placed.Additionally, the device was removed from its hoop to inspect the brown paint and was observed that it was scraped.No other issues with the device were noted.The reported event was confirmed.The foreign material matches with the brown paint which indicates that it was a residue of the scraped paint.As per complaint information the issue occurred during preparation and the unit returned out of its original pouch indicating handling and manipulation of the product.Handling and manipulation of the device during prepping could have contributed with the event.It is possible the user pulled the extrusion against the edge of the hoop during removal and it scraped the paint.Therefore, the most probable root cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occured during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that a rapid exchange was unpacked for an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during preparation outside the patient, package of rapid exchange was opened and when device was taken out from the sheath, there was dirt-like foreign object found on the tip part of the catheter.The procedure was completed with a second tandem rx cannula.There were no patient complications reported as a result of this event.

• Brand Name: RAPID EXCHANGE
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9693752
• Report Number: 3005099803-2020-00313
• Device Sequence Number: 1809984
• Product Code: GCJ
• UDI-Device Identifier: 08714729301905
• UDI-Public: 08714729301905
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 04/09/2020

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: 10/01/2021
• Device Model Number: M00545820
• Device Catalogue Number: 4582
• Device Lot Number: 0024529848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2020
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 03/16/2020
• Initial Report FDA Received Date: 02/11/2020
• Supplement Report FDA Received Date: 04/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1