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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE COYOTE¿ ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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BOSTON SCIENTIFIC - MAPLE GROVE COYOTE¿ ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number H74939134254010
Device Problems Detachment Of Device Component (1104); Material Rupture (1546)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 02/21/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that balloon rupture and balloon detachment occurred. The stenotic target lesion was located in a vessel in a lower extremity. A 2. 5mm x 40mm x 145 cm coyote¿ es balloon catheter was advanced for dilatation. However, during inflation, the balloon ruptured. A piece of the balloon came off from catheter and was left in the patient. No patient complications were reported and the patient's status was fine.
 
Manufacturer Narrative
Device evaluated by mfr. , eval summary attached, method codes, result codes, conclusion codes updated. Device evaluated by mfr. : returned device consisted of a coyote es balloon catheter with blood in the balloon, inflation lumen and wire lumen. The balloon was loosely folded. The balloon, markerbands, inner/outer shaft and proximal weld were microscopically and tactile inspected. Inspection revealed that only 2 cm from the balloon was returned with a complete circumferential tear in the balloon material, the distal tip was missing; part of the inner shaft was missing and the inner shaft was completely separated with approximately 2-4 mm missing from the device. Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities. 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).
 
Event Description
It was reported that balloon rupture and balloon detachment occurred. The stenotic target lesion was located in a vessel in a lower extremity. A 2. 5mm x 40mm x 145cm coyote¿ es balloon catheter was advanced for dilatation. However, during inflation, the balloon ruptured. A piece of the balloon came off from catheter and was left in the patient. No patient complications were reported and the patient's status was fine.
 
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Brand NameCOYOTE¿ ES
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
MDR Report Key7352551
MDR Text Key102873580
Report Number2134265-2018-01845
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
PMA/PMN Number
K080982
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 02/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2018
Device Model NumberH74939134254010
Device Catalogue Number39134-25401
Device Lot Number0020112026
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/05/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/24/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 03/20/2018 Patient Sequence Number: 1
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