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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NC EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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BOSTON SCIENTIFIC CORPORATION NC EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 7213
Device Problems Material Puncture/Hole (1504); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/01/2022
Event Type  malfunction  
Manufacturer Narrative
Date of event: used the first date of the month of the aware date as no event date was provided.
 
Event Description
It was reported that hole in the catheter occurred.During procedure, a 4.00mm x 15mm nc emerge balloon catheter was selected for use.However, when the balloon was attempted to load on a.014 guidewire, the wire would not feed through the balloon lumen and shaft hole was noted.A new nc emerge balloon catheter was replaced, and the procedure was completed successfully.There were no patient complications reported.
 
Manufacturer Narrative
Returned product consisted of an nc emerge balloon catheter.The device was visually and microscopically examined.There was heavy contrast present in the inflation lumen and blood in the guidewire lumen.The guidewire lumen was buckled and prolapsed 2mm distal from the bicomponent weld, at 1mm in length.The balloon had tight folds.Further inspection of the remainder of the device presented no other damage or irregularities.The guidewire used in the procedure was not returned for analysis, so a test 0.014 guidewire was used for functional testing.The guidewire failed to pass through the device; it fed onto the tip of the device and failed to pass due to the buckle.Analysis could not confirm the reported puncture in the lumen as no hole was detected in analysis.
 
Event Description
It was reported that hole in the catheter occurred.During procedure, a 4.00mm x 15mm nc emerge balloon catheter was selected for use.However, when the balloon was attempted to load on a.014 guidewire, the wire would not feed through the balloon lumen and shaft hole was noted.A new nc emerge balloon catheter was replaced, and the procedure was completed successfully.There were no patient complications reported.Returned product consisted of an nc emerge balloon catheter.The device was visually and microscopically examined.There was heavy contrast present in the inflation lumen and blood in the guidewire lumen.The guidewire lumen was buckled and prolapsed 2mm distal from the bicomponent weld, at 1mm in length.The balloon had tight folds.Further inspection of the remainder of the device presented no other damage or irregularities.The guidewire used in the procedure was not returned for analysis, so a test 0.014 guidewire was used for functional testing.The guidewire failed to pass through the device, but it fed onto the tip of the device and failed to pass due to the buckle.Product analysis confirmed the reported failure to load on wire, as the guidewire lumen was buckled and prolapsed.The damage is likely consistent with an interaction with a guidewire and could cause difficulty advancing.Analysis could not confirm the reported puncture in the lumen as no hole was detected in analysis.
 
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Brand Name
NC EMERGE
Type of Device
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key15554075
MDR Text Key304356867
Report Number2124215-2022-39939
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08714729846567
UDI-Public08714729846567
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141236
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/01/2022
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 Date02/10/2024
Device Model Number7213
Device Catalogue Number7213
Device Lot Number0028843090
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/22/2022
Initial Date FDA Received10/06/2022
Supplement Dates Manufacturer Received10/31/2022
Supplement Dates FDA Received11/01/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/10/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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