• 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 M001BP50620B0
Device Problems Balloon (419); Cutter/Blade (777); Difficult to Remove (1528); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/22/2015
Event Type  Malfunction  
Event Description

It was reported that a cutting balloon blade was lifted. The 95% stenosed target lesion was located in the moderately calcified and moderately tortuous right above the graft anastomotic site vein. A non bsc introducer sheath was advanced. After a non-bsc guidewire crossed the lesion, a 6. 00mcm / 2. 0cm/ 50cm peripheral cutting balloon¿ was selected and advanced to treat the lesion. The physician attempted to withdraw the device but resistance was encountered in retracting the device into a non bsc sheath. The physician elected to remove the balloon and the sheath together. When the physician checked the device, it was noted that a part the blade was lifted. It was further reported that the blade was not detached completely. The procedure was completed with this device. No patient complications were reported and the patient's status was good.

 
Manufacturer Narrative

Age at time of event: 18 years or older. (b)(4).

 
Manufacturer Narrative

Device evaluated by mfr: the device was returned through a 7 fr introducer sheath. Device analysis noted that the introducer sheath was damaged at its proximal end and approximately 10mm of the proximal end of the balloon of the device was still inside the introducer sheath. A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure. A microscopic examination identified that approximately 5 mm of the proximal end of a blade was lifted from the balloon; however, no section was detached. The blade pad was intact. A microscopic examination observed no damage to the additional blades. These blades were present and fully bonded to the balloon surface. No damage was noted to the tip or balloon of the device. No kinks or damage were noticed along the shaft of the device. Resistance was encountered during removal of the returned unit from the sheath as a result of the damage to the sheath and also due to the damage to the blade. The complaint device was connected to an encore inflation unit and a vacuum was pulled for balloon preparation prior to advancement through the recommended size 7 fr sheath as identified on the product label. The catheter was advanced through the sheath and positive pressure was applied. The balloon was able to be inflated to its rated burst pressure of 10atmospheres and maintained pressure with no leaks noted. The device was deflated and removed through the sheath without issue. No kinks or damage were noticed along the shaft of the device. 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 that a cutting balloon blade was lifted. The 95% stenosed target lesion was located in the moderately calcified and moderately tortuous right above the graft anastomotic site vein. A non bsc introducer sheath was advanced. After a non-bsc guidewire crossed the lesion, a 6. 00mcm / 2. 0cm/ 50cm peripheral cutting balloon was selected and advanced to treat the lesion. The physician attempted to withdraw the device but resistance was encountered in retracting the device into a non bsc sheath. The physician elected to remove the balloon and the sheath together. When the physician checked the device, it was noted that a part the blade was lifted. It was further reported that the blade was not detached completely. The procedure was completed with this device. No patient complications were reported and the patient's status was good.

 
Manufacturer Narrative

Device evaluated by mfr: device analysis noted that the introducer sheath was damaged at its distal end. (b)(4).

 
Event Description

It was reported that a cutting balloon blade was lifted. The 95% stenosed target lesion was located in the moderately calcified and moderately tortuous right above the graft anastomotic site vein. A non bsc introducer sheath was advanced. After a non-bsc guidewire crossed the lesion, a 6. 00mcm / 2. 0cm/ 50cm peripheral cutting balloon was selected and advanced to treat the lesion. The physician attempted to withdraw the device but resistance was encountered in retracting the device into a non bsc sheath. The physician elected to remove the balloon and the sheath together. When the physician checked the device, it was noted that a part the blade was lifted. It was further reported that the blade was not detached completely. The procedure was completed with this device. No patient complications were reported and the patient's status was good.

 
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
ballybrit business park
galway
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
ballybrit business park
galway
Manufacturer Contact
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key4781609
MDR Text Key22248261
Report Number2134265-2015-02971
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 Foreign,Health Professional,Company Representative,Distributor,COMPANY REPRESENT
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/22/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/19/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/07/2017
Device MODEL NumberM001BP50620B0
Device Catalogue NumberBP506020B
Device LOT Number0017584294
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/27/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/04/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/27/2015
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: 05/19/2015 Patient Sequence Number: 1
Treatment
GUIDEWIRE: KYOUSHANT; INTRODUCER SHEATH: MEDIKIT
-
-