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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE EMERGE¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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BOSTON SCIENTIFIC - MAPLE GROVE EMERGE¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number H7493919320300
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/24/2016
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older. (b)(4). Device evaluated by mfr: 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 medwatch will be filed. (b)(4).
 
Event Description
It was reported that a shaft break occurred. The target lesion was located in the severely calcified left anterior descending (lad) artery. A 3. 00mm x 20mm emerge¿ balloon catheter was advanced to the lad and could not cross the lesion. The catheter was pushed "hard" and broke on a portion outside of the patient, approximately 20cm from the proximal end. There were no patient complications reported and the patient is in good condition.
 
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an emerge balloon catheter. The balloon was tightly folded and there was contrast in the inflation lumen. The balloon, hypotube, inner and outer shafts were microscopically and tactile examined. Inspection revealed numerous kinks in the hypotube, with a separation 16. 5 cm from the strain relief. The ends of the separation were oval, as if kinked prior to separation. Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The most probable root cause is operational context as device performance was limited due to anatomical procedural factors. (b)(4).
 
Event Description
It was reported that a shaft break occurred. The target lesion was located in the severely calcified left anterior descending (lad) artery. A 3. 00 mm x 20 mm emerge¿ balloon catheter was advanced to the lad and could not cross the lesion. The catheter was pushed "hard" and broke on a portion outside of the patient, approximately 20 cm from the proximal end. There were no patient complications reported and the patient is in good condition.
 
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Brand NameEMERGE¿
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key6185139
MDR Text Key62705048
Report Number2134265-2016-12012
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
PMA/PMN Number
K113220
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/01/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2019
Device Model NumberH7493919320300
Device Catalogue Number39193-2030
Device Lot Number19405186
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/21/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/12/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/25/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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