• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY 2CM PERIPHERAL CUTTING BALLOON¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC - GALWAY 2CM PERIPHERAL CUTTING BALLOON¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA Back to Search Results
Model Number M001BP35520B0
Device Problems Cutter/Blade (777); Bent (1059); Detachment Of Device Component (1104)
Patient Problem Pain (1994)
Event Date 06/09/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported the patient felt pain and a blade detached. During a percutaneous transluminal angioplasty (pta) in the superficial femoral artery (sfa) popliteal, the physician was using a 2cm peripheral cutting balloon¿. The patient felt some pain during dilation. The device was being removed with normal resistance from the patient when it was noted the blade lifted. After the device was fully removed from the patient the blade detached from the balloon. The procedure was completed with another of the same device. No patient complications were reported and the patient status was stable.

 
Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis. An examination of the balloon and blade found that the detached blade was measured at 7mm. The balloon was inflated using an encore inflation device to get a better view of the blades. It was noted that 7mm of blade had partially detached from the proximal end of one of the blades on the balloon. The remaining 13mm of the blade and pad was undamaged. The remaining blades on the device were analyzed and no issues were noted. No issues were noted with the shaft polymer extrusion. A visual and tactile examination of the hypotube found no kinks or damage along the shaft of the device. 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

It was reported the patient felt pain and a blade detached. During a percutaneous transluminal angioplasty (pta) in the superficial femoral artery (sfa) popliteal, the physician was using a 2cm peripheral cutting balloon. The patient felt some pain during dilation. The device was being removed with normal resistance from the patient when it was noted the blade lifted. After the device was fully removed from the patient the blade detached from the balloon. The procedure was completed with another of the same device. No patient complications were reported and the patient status was stable.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name2CM PERIPHERAL CUTTING BALLOON¿
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
Manufacturer Contact
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key5774740
MDR Text Key48922180
Report Number2134265-2016-06141
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
PMA/PMN NumberK070951
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 06/09/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/07/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/19/2017
Device MODEL NumberM001BP35520B0
Device Catalogue NumberBP1355020B
Device LOT Number18315732
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/24/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/13/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/16/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/07/2016 Patient Sequence Number: 1
-
-