MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPTIVATOR EMR; ENDOSCOPE AND/OR ACCESSORIES

Model Number M00561600

Device Problems Retraction Problem (1536); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/12/2020

Event Type  Injury  

Manufacturer Narrative

The complainant reported that the upn was (b)(4), and lot number of was 0025284913; however, both numbers could not be found in the system.Thus, the manufacture date and expiration date are unknown.(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a captivator endoscopic mucosal resection device was used during a ligation assisted endoscopic mucosal resection (emr) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the physician noticed that the snare was not cutting through or closing as efficiently as expected when trying to cut through a ligation assisted lesion.It was noted that while still trying to cut through the tissue, the snare loop was completely dislodged from the snare wire.Reportedly, the detached loop was removed by using grasping forceps.The customer sent a photo, and a detachment piece of the snare loop was observed.The procedure was completed with another captivator endoscopic mucosal resection device.The patient condition at the conclusion of the procedure was reported to be stable.

Event Description

It was reported to boston scientific corporation that a captivator endoscopic mucosal resection device was used during a ligation assisted endoscopic mucosal resection (emr) procedure performed on (b)(6), 2020.According to the complainant, during the procedure, the physician noticed that the snare was not cutting through or closing as efficiently as expected when trying to cut through a ligation assisted lesion.It was noted that while still trying to cut through the tissue, the snare loop was completely dislodged from the snare wire.Reportedly, the detached loop was removed by using grasping forceps.The customer sent a photo, and a detachment piece of the snare loop was observed.The procedure was completed with another captivator endoscopic mucosal resection device.The patient condition at the conclusion of the procedure was reported to be stable.**additional information received on (b)(6) 2020** the anatomy location of the procedure was in the gastroesophageal junction (gej).

Manufacturer Narrative

Block d4, h4: the complainant was unable to report the device lot number; therefore the manufacture date and expiration dates are unknown.Block h6: device code 2907 captures the reportable event of loop detachment.Conclusion code 4316 is being used in lieu of an adequate conclusion code for "device not returned".Block h10: according to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.Additional information: block b5 (anatomy location), block d4 (model number, catalog number and unique identifier (udi) #), block d8 (sud reprocessed and reused), block e1 (initial reporter phone), block h8 (usage of device), block h10 (additional mfr narrative).

• Brand Name: CAPTIVATOR EMR
• Type of Device: ENDOSCOPE AND/OR ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10969699
• MDR Text Key: 220640965
• Report Number: 3005099803-2020-05934
• Device Sequence Number: 1
• Product Code: FDI
• Combination Product (y/n): N
• PMA/PMN Number: K140726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/04/2021

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
• Device Operator: Health Professional
• Device Model Number: M00561600
• Device Catalogue Number: 50662
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/16/2020
• Initial Date FDA Received: 12/08/2020
• Supplement Dates Manufacturer Received: 12/13/2020
• Supplement Dates FDA Received: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention