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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 M001PCB8020900
Device Problems Balloon; Detachment Of Device Component; Entrapment of Device; Torn Material
Event Date 07/15/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Device evaluated by mfr: it is indicated that the device will not be returned for evaluation. A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted. If there is any further relevant information from that review, a supplemental medwatch will be filed. (b)(4).

 
Event Description

It was reported that the balloon ripped and became stuck. An 8. 00mm/2. 0cm/90cm peripheral cutting balloon® was selected for use. During the procedure, it was noted that the balloon ruptured and ripped. Subsequently, the balloon became stuck. No patient complications were reported.

 
Manufacturer Narrative

Ae or product problem corrected from product problem to reported issue both an adverse event and product problem. Outcomes attributed to ae, describe event or problem, name prefix, last name, patient codes, device codes updated. (b)(4).

 
Event Description

It was further reported that the physician attempted to pull the balloon catheter into the guide catheter; however, the balloon snapped off. Snaring was done to remove the balloon out from the patient's body. Patient's condition after the procedure was stable.

 
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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 Key5869217
Report Number2134265-2016-07016
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 07/15/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/11/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/25/2018
Device MODEL NumberM001PCB8020900
Device Catalogue NumberPCB802090
Device LOT Number19183732
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/11/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/13/2016
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: 08/11/2016 Patient Sequence Number: 1
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