MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH INTERJECT¿; BIOPSY NEEDLE KIT

Model Number	M00518311
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 interject¿ needle was used in the esophagus during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2018.According to the complainant, during preparation, the lauromacrogol couldn't be injected.The procedure was completed with another interject¿ needle.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.
Additional Manufacturer Narrative
An interject needle was returned for analysis.A visual evaluation of the returned device found that it was in good conditions without evidence of damage, specifically the needle itself did not present any issues.A functional evaluation revealed that water was injected through the returned device by its proximal end using a syringe and the water could exit by the needle (distal end) without problems.The complaint was not confirmed.The returned device showed no evidence of the alleged issues, or any defect which could have contributed to the event, therefore the most probable cause is ¿not confirmed returned¿ since the complaint included a returned device review (visual, physical, and performance testing) which showed no evidence of either the alleged issue or any defect which could have contributed to the event.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.A search of the complaint database revealed that no similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that an interject needle was used in the esophagus during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2018.According to the complainant, during preparation, the lauromacrogol couldn't be injected.The procedure was completed with another interject needle.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: INTERJECT¿
• Common Device Name: BIOPSY NEEDLE KIT
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 7513917
• Report Number: 3005099803-2018-01507
• Device Sequence Number: 13892953
• Product Code: FCG
• UDI-Device Identifier: 08714729296515
• UDI-Public: 08714729296515
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K012864
• 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): 04/26/2018

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: 01/02/2021
• Device Model Number: M00518311
• Device Catalogue Number: 1831
• Device Lot Number: 21562189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2018
• Initial Date Received by Manufacturer: 04/26/2018
• Supplement Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 05/15/2018
• Supplement Report FDA Received Date: 06/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1