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

Model Number	M00545820
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Healthcare professional that completed the initial complaint form to the competent authority: (b)(6), pharmacist.(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem 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 rapid exchange cannula device was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed in the pancreatic duct (channel of wirsung) on (b)(6) 2020.According to the complainant, during the procedure, it was noticed that the radiopaque (ro) marker was detached inside the patient.There is no information if an attempt was made to retrieve the detached ro marker.The procedure was completed with a second tandem rapid exchange cannula.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a tandem rapid exchange cannula device was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed in the pancreatic duct (channel of wirsung) on (b)(6), 2020.According to the complainant, during the procedure, it was noticed that the radiopaque (ro) marker was detached inside the patient.There is no information if an attempt was made to retrieve the detached ro marker.The procedure was completed with a second tandem rapid exchange cannula.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1: healthcare professional that completed the initial complaint form to the competent authority: (b)(6) block h6 (device codes): the problem code 2907 captures the reportable event of ro marker detached.Block h10: the returned tandem rapid exchange cannula was analyzed, and a visual evaluation noted that the working length was kinked.Additionally, the radiopaque (ro) marker was not present in the device.The device was observed under magnification and the guidewire lumen was completely torn.The tip was also found damaged.No other problems with the device were noted.The reported event of ro marker band detached was confirmed.A label review was performed, and from the information available, this device was used in a manner inconsistent with the instructions for use (ifu).Upon analysis of the returned device, it was found that the guidewire lumen was completely torn, which is evidence that the guidewire was withdrawn from the catheter incorrectly as the ifu states, "upon completion of peeling the guidewire to biopsy valve, lock the guidewire into locking feature of the rx locking device.Withdraw the cannula from the scope until the distal open channel marker is visible at the rx locking device and resistance is felt.Perform standard exchange procedure over the final 25 cm of the rapid exchange xl cannula.Once the distal blue tip is exposed from the rx locking device, relock the guidewire and pull the rapid exchange xl cannula off the wire".Taking all available information into consideration, the investigation concluded that the reported event and the observed failures were likely due to the user not following the manufacturer's instructions.Therefore, the most probable cause is failure to follow instructions.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Block h11 (correction): distributor has been added in block g3 (report source).

• 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: 11020220
• Report Number: 3005099803-2020-05842
• Device Sequence Number: 19898594
• Product Code: GCJ
• UDI-Device Identifier: 08714729301905
• UDI-Public: 08714729301905
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K970054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/23/2022
• Device Model Number: M00545820
• Device Catalogue Number: 4582
• Device Lot Number: 0026064186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2020
• Initial Date Received by Manufacturer: 11/24/2020
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 01/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 52