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

Model Number	M00545820
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).A visual examination of the returned device found that the working length torn from the c-channel to the distal tip.The radiopaque (ro) marker was not present and was not returned for analysis.An examination of the working length found marks indicating that the ro marker had been placed inside the lumen during manufacturing.The complaint was consistent with the reported event of radiopaque (ro) marker detached.The evaluation concluded the user most likely pulled the guidewire through the guidewire lumen tearing the extrusion to the distal tip.Subsequently, the ro marker was no longer secured inside the guidewire lumen and the ro marker then was able to fall out of the device.Therefore, the most probable root cause is "operational context" a dhr (device history record) review was performed and no deviation was found.A search of the complaint database confirmed that no other complaints exist for the specified batch.Labeling review was performed and no anomalies were found.
Event or Problem Description
It was reported to boston scientific corporation that an tandem rx cannula was used in the pancreas during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2017.According to the complainant, during the procedure, an examination of the pancreatic duct was performed using this device.After this device was removed, a dot in the pancreatic duct was noticed on the x-ray image.In the physician¿s assessment, it was reported that it was the radiopaque (ro) marker of the tandem that had detached during the examination of the pancreatic duct.The ro marker was successfully retrieved.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 stable.

• 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: 6885283
• Report Number: 3005099803-2017-02876
• Device Sequence Number: 483998
• Product Code: GCJ
• UDI-Device Identifier: 08714729301905
• UDI-Public: 08714729301905
• 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
• Report Date (Section B): 08/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/19/2019
• Device Model Number: M00545820
• Device Catalogue Number: 4582
• Device Lot Number: 20787243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2017
• Initial Report FDA Received Date: 09/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention