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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION 2CM PERIPHERAL CUTTING BALLOON; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
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BOSTON SCIENTIFIC CORPORATION 2CM PERIPHERAL CUTTING BALLOON; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA Back to Search Results
Model Number 24630
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/24/2020
Event Type  malfunction  
Event Description
It was reported that there was foreign matter inside the sterile packaging.A 7.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.At the course of the procedure, it was noted that hair was found inside the sterile packaging.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.The outer carton was opened.The inner pouch had also been opened.A visual examination identified foreign matter with the characteristics of a hair was inside the opened pouch.No other issues were identified during the product analysis.
 
Event Description
It was reported that there was foreign matter inside the sterile packaging.A 7.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.At the course of the procedure, it was noted that hair was found inside the sterile packaging.No patient complications were reported.
 
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Brand Name
2CM PERIPHERAL CUTTING BALLOON
Type of Device
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9949292
MDR Text Key187246732
Report Number2134265-2020-04801
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 07/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/03/2021
Device Model Number24630
Device Catalogue Number24630
Device Lot Number0024705867
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/03/2020
Date Manufacturer Received06/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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