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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 H7493918915200
Device Problems Break (1069); Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 04/20/2017
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
Same case as mdr id# 2134265-2017-04637. It was reported that shaft break occurred. During unpacking of a 2. 00mm x 15mm and 1. 50mm x 15mm emerge¿ balloon catheters, both devices were noted to be broken in half. The devices never entered the patient's body. No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of the emerge balloon catheter in two pieces. The hypotube and shaft were microscopically examined. There was contrast in the inflation lumen and blood in the guidewire lumen. The balloon was tightly folded. Although it was reported that the device was not used, the presence of blood and contrast media in the inflation and guidewire lumens is indicative of handling beyond simply unpackaging the device, as was reported. There were numerous kinks throughout the hypotube and there was a complete hypotube separation 22cm from the strain relief. The hypotube fracture surface was ovaled, which suggests the device was kinked prior to separation. The tip was damaged. Inspection of the remainder of the device revealed no other damage or irregularities. No other issues were identified during the product analysis. 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
Same case as mdr id# 2134265-2017-04637. It was reported that shaft break occurred. During unpacking of a 2. 00mm x 15mm and 1. 50mm x 15mm emerge¿ balloon catheters, both devices were noted to be broken in half. The devices never entered the patient's body. No patient complications were reported.
 
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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 Key6546424
MDR Text Key74489633
Report Number2134265-2017-04636
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113220
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/21/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/04/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2019
Device Model NumberH7493918915200
Device Catalogue Number39189-1520
Device Lot Number20462572
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/17/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/22/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/31/2017
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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