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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - MAPLE GROVE AGENT CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number H74939222201510
Device Problem Bent (1059)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
This device is a combination product. (b)(4). Device evaluated by mfr: returned product consisted of an agent drug coated balloon. Microscopic, tactile and visual inspection of the device consisted of checking the device for damage along the hub, inner/outer shaft, balloon, markerband, and tip of the device. The balloon was tightly folded. Inspection revealed inner/outer shaft damage (kinked/flattened/perforations) located 48 mm from the tip of the device, inner shaft damage (stretched/flattened) located 48mm form the tip of the device. Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities. Although it was reported that the device was not used, the damage to the shaft/lumens is indicative of handling beyond simply unpackaging the device, as was reported. The reported tip damage was not confirmed. The damage is consistent with difficulty loading a guide wire onto the catheter. The investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event. (b)(4).
 
Event Description
Reportable based on device analysis completed on 12-jan-2018. It was reported that during unpacking, the 2. 00 mm x 15. 00 mm agent balloon catheter tip was out of shape. No patient complications were reported and the patient's status was stable. However, device analysis shaft perforation. This product is only ous approved but is similar to an approved us device.
 
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Brand NameAGENT
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 Key7249153
MDR Text Key99331145
Report Number2134265-2018-00421
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
PMA/PMN Number
SIMILAR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 01/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2019
Device Model NumberH74939222201510
Device Catalogue Number39222-20151
Device Lot Number3619H17
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/27/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/12/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/19/2017
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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