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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACQUIRE; ENDOSCOPIC ULTRASOUND SYSTEM, GASTROENTEROLOGY-UROLOGY
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BOSTON SCIENTIFIC CORPORATION ACQUIRE; ENDOSCOPIC ULTRASOUND SYSTEM, GASTROENTEROLOGY-UROLOGY Back to Search Results
Model Number M00555640
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pancreatitis (4481)
Event Date 12/13/2023
Event Type  Injury  
Event Description
It was reported to boston scientific corporation that an acquire needle was used during an endoscopic ultrasound-guided fine needle aspiration (eus-fna) procedure performed on (b)(6) 2023.During the procedure there were no issues with the first two punctures; however, after the third puncture almost no specimen was obtained.In order to obtain a large amount of specimen, the puncture was performed five times.Post-procedure, the patient developed pancreatitis which in the physician's assessment was not due to a device defect.There was no information on how the pancreatitis was treated.The procedure was completed with the original device.
 
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.However, the complainant reported that the device was not expired.Block h6: imdrf patient code e1021 captures the reported patient complication of pancreatitis.
 
Manufacturer Narrative
Block h2: additional information was received on january 5, 2024, that the lot is either 32002533 or 31915173; however, it is unknown which one.Lot 32002533: manufacture date 07/12/2023 and use before date/expiration 07/11/2026.Lot 31915173: manufacture date 06/28/2023 and use before date/expiration 06/27/2026.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.However, the complainant reported that the device was not expired.Block h6: imdrf patient code e1021 captures the reported patient complication of pancreatitis.
 
Event Description
It was reported to boston scientific corporation that an acquire needle was used during an endoscopic ultrasound-guided fine needle aspiration (eus-fna) procedure performed on (b)(6) 2023.During the procedure there were no issues with the first two punctures; however, after the third puncture almost no specimen was obtained.In order to obtain a large amount of specimen, the puncture was performed five times.Post-procedure, the patient developed pancreatitis which in the physician's assessment was not due to a device defect.There was no information on how the pancreatitis was treated.The procedure was completed with the original device.
 
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Brand Name
ACQUIRE
Type of Device
ENDOSCOPIC ULTRASOUND SYSTEM, GASTROENTEROLOGY-UROLOGY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
780 brookside drive
spencer IN 47460
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key18457378
MDR Text Key332255848
Report Number3005099803-2023-06996
Device Sequence Number1
Product Code ODG
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K223616
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/24/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberM00555640
Device Catalogue Number5564
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/05/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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