MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACQUIRE; ENDOSCOPIC ULTRASOUND SYSTEM, GASTROENTEROLOGY-UROLOGY

Model Number	M00555540
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(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 an acquire needle was used in the pancreas tail during a tissue biopsy procedure performed on (b)(6) 2021.During the procedure, when the needle was withdrawn, the tip of the needle broke off and remained in the stomach.The needle tip was removed from the stomach with a snare and a new acquire needle was used to complete the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block d4 and h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: device code a0501 captures the reportable event of needle detached.Block h10: investigation results: the returned acquire needle was analyzed, a visual evaluation was performed and it was observed that the needle broke off.The broken ends of the needle were inspected showing that it was bent before the break.In addition, the working length had several kinks.A functional evaluation noted that when the handle was actuated, the needle was able to extend/retract normally.The stylet could be removed and re inserted without problems as well.No other issues were noted.Based on all available information and the condition of the returned device, the bent needle could have led to the needle breaking off.The bent needle could have been caused by some technique applied by the costumer during the procedure and/or some interaction with another device could have also contributed on this issue.Once the needle was bent some tough movement could have caused the break.The investigation concluded the most probable cause is adverse event related to procedure.A manufacturing batch record review was unable to be performed as the lot number is unknown.However, a ship history review was performed to identify the most probable lots, and a device history record (dhr) review on the most probable lots did not identify any deviations within manufacturing/service processes that could have contributed to the event.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that an acquire needle was used in the pancreas tail during a tissue biopsy procedure performed on (b)(6) 2021.During the procedure, when the needle was withdrawn, the tip of the needle broke off and remained in the stomach.The needle tip was removed from the stomach with a snare and a new acquire needle was used to complete the procedure.There were no patient complications reported as a result of this event.

• Brand Name: ACQUIRE
• Common Device Name: ENDOSCOPIC ULTRASOUND SYSTEM, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12320783
• Report Number: 3005099803-2021-03757
• Device Sequence Number: 3723309
• Product Code: ODG
• UDI-Device Identifier: 08714729931782
• UDI-Public: 08714729931782
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K160845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2021

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
• Operator of Device: Health Professional
• Device Model Number: M00555540
• Device Catalogue Number: 5554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2021
• Initial Date Received by Manufacturer: 07/20/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 08/13/2021
• Supplement Report FDA Received Date: 10/04/2021
• 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