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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - MAPLE GROVE NC QUANTUM APEX¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number H7493912415220
Device Problems Detachment Of Device Component (1104); Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/24/2018
Event Type  malfunction  
Manufacturer Narrative
(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 balloon rupture and detachment occurred. A 15mm x 2. 25mm nc quantum apex¿ balloon catheter was advanced for dilation. However, during inflation the balloon ruptured. Furthermore, when the device was removed, it was noted that the balloon portion was separated. No patient complications were reported and the patient's status was okay.
 
Manufacturer Narrative
Device returned to mfr. , device evaluated by mfr. Last name corrected from (b)(6) to (b)(6). Initial reporter phone corrected from (b)(6) to (b)(6). Occupation corrected from health professional to physician. (b)(4).
 
Event Description
It was further reported that the target lesion was located in a mildly tortuous and mildly calcified vessel. On the fourth inflation at 20 atmospheres for 15 seconds, the balloon ruptured. The device was completely removed from the patient's body.
 
Event Description
It was further reported that the target lesion was located in a mildly tortuous and mildly calcified vessel. On the fourth inflation at 20 atmospheres for 15 seconds, the balloon ruptured. The device was completely removed from the patient's body.
 
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an nc quantum apex balloon catheter. The balloon was loosely folded with blood in the lumen and balloon. The outer shaft, inner shaft, balloon and tip were microscopically examined. There are numerous hypotube and shaft kinks. Microscopic examination of the device presented that a portion of the outer shaft was plastically deformed proximal of the proximal balloon weld which also has a 8mm longitudinal tear. The balloon is intact and has no damage. There was no evidence of any material or manufacturing deficiencies contributing to the damage. There is no indication the device was inflated over the rated burst pressure. The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited. (b)(4).
 
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Brand NameNC QUANTUM APEX¿
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
MDR Report Key7621952
MDR Text Key111901470
Report Number2134265-2018-05462
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
PMA/PMN Number
K121667
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 05/25/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/01/2021
Device Model NumberH7493912415220
Device Catalogue Number39124-1522
Device Lot Number21937404
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/02/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/27/2018
Is This a Reprocessed and Reused Single-Use Device? No

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