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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROFILE; SNARE, FLEXIBLE

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BOSTON SCIENTIFIC CORPORATION PROFILE; SNARE, FLEXIBLE Back to Search Results
Model Number M00562531
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/01/2021
Event Type  malfunction  
Manufacturer Narrative
The exact date of the event is unknown.The provided event date of (b)(6) 2021 was chosen as a best estimate based on the date that the manufacturer became aware of the event.The initial reporter's address is (b)(6).This event was reported by the distributor.The reported physician and healthcare facility are: (b)(6).(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon 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 Description
It was reported to boston scientific corporation that a profile extra small oval flexible snare was inspected before delivery to the customer performed on an unknown date.It was reported that something that looked like an eyelashes was found inside the unopened sterile pouch.Reportedly, this was found before delivery to the customer and there was no patient involvement.
 
Event Description
It was reported to boston scientific corporation that a profile extra small oval flexible snare was inspected before delivery to the customer performed on an unknown date.It was reported that something that looked like an eyelashes was found inside the unopened sterile pouch.Reportedly, this was found before delivery to the customer and there was no patient involvement.
 
Manufacturer Narrative
Block b3: the exact date of the event is unknown.The provided event date of (b)(6), 2021 was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block e1: the initial reporter's address is (b)(6) block e1: this event was reported by the distributor.The reported physician and healthcare facility are: (b)(6)block h6: problem code a180104 captures the reportable event of foreign material present on device.Block h10: investigation results a profile extra small oval flexible snare was received for analysis.Visual, microscopic and media inspection of the returned device revealed that a hair was found inside the original and unopened pouch.No other problems were noted.The device was returned for analysis and a hair was found inside the original sealed device pouch, confirming the reported event.An investigation was initiated to determine the cause of this event.It was found that this is an isolated incident, and it is possible that the cause could be due to an oversight on the production line and/or conditions of the clean room.There are processes in place during the manufacturing process to inspect and confirm that sealed pouches do not contain particulate or foreign matter.Although a definitive root cause was unable to be determined, since the product was returned sealed with the hair inside the pouch, the most probable cause of the event is a manufacturing deficiency.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
 
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Brand Name
PROFILE
Type of Device
SNARE, FLEXIBLE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key12542016
MDR Text Key273635168
Report Number3005099803-2021-04924
Device Sequence Number1
Product Code FDI
UDI-Device Identifier08714729156628
UDI-Public08714729156628
Combination Product (y/n)N
PMA/PMN Number
K131700
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/03/2021
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
Device Operator Health Professional
Device Expiration Date04/05/2024
Device Model NumberM00562531
Device Catalogue Number6253
Device Lot Number0027084970
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/23/2021
Initial Date Manufacturer Received 09/03/2021
Initial Date FDA Received09/28/2021
Supplement Dates Manufacturer Received10/08/2021
Supplement Dates FDA Received11/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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