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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - GALWAY 2CM PERIPHERAL CUTTING BALLOON® CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA Back to Search Results
Model Number M001PCB6020900
Device Problems Cutter/Blade (777); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/30/2015
Event Type  Malfunction  
Event Description

It was reported that a cutting balloon blade was partially lifted. A 6. 00mm x 2. 00cm x 90 cm peripheral cutting balloon® was selected and advanced to treat the target lesion. During the procedure, it was noted that a piece of metal was sticking out of the balloon. The procedure was completed with another of the same device. No patient complications were reported and the patient's status was fine.

 
Manufacturer Narrative

(b)(4).

 
Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis. A visual examination noted that approximately 4mm of the proximal end of one blade had lifted from the balloon's proximal body; however, the blade pad was still intact. The remaining blades were fully bonded to the balloon and no damage was noted to the other blades. A visual and microscopic examination observed no damage to the tip. A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure. An examination of the markerbands identified no issues which could potentially have contributed to this complaint. The returned device was attached to an encore inflation unit. Positive pressure was applied. No leak was noted. The balloon was inflated to its rated burst pressure of 10 atmospheres. The balloon inflated and deflated successfully. The encore inflation unit was verified before and after use using a calibrated pressure gauge. No kinks or damage were noticed along the shaft of the device. No other issues were noted during 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 that a cutting balloon blade was partially lifted. A 6. 00mm x 2. 00cm x 90 cm peripheral cutting balloon® was selected and advanced to treat the target lesion. During the procedure, it was noted that a piece of metal was sticking out of the balloon. The procedure was completed with another of the same device. No patient complications were reported and the patient's status was fine.

 
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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 Key4801897
MDR Text Key19723909
Report Number2134265-2015-03191
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK070951
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 05/01/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/28/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/19/2016
Device MODEL NumberM001PCB6020900
Device Catalogue NumberPCB602090
Device LOT Number16982793
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/05/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/27/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/10/2014
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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