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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYMMETRY¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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BOSTON SCIENTIFIC - GALWAY SYMMETRY¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number M001103320
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Vasoconstriction (2126)
Event Date 10/04/2017
Event Type  Injury  
Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis. The balloon material appeared slightly unfolded and wrinkled. The investigator successfully inflated and deflated the balloon and no issues were noted with the balloon material during or after deflation of the balloon material. A visual and microscopic examination identified no damage or any issues with the balloon material that could have contributed to the complaint incident. A visual and tactile examination of the shaft identified no damage or any issues along the length of the device. An examination of the markerbands and tip identified no issues that could have potentially contributed to the complaint incident. 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 investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited. (b)(4).
 
Event Description
It was reported that vessel spasm occurred. The 90% stenosed target lesion was located in a moderately tortuous, moderately calcified shunt. A 5. 0-4/4t/90mm symmetry balloon catheter was advanced for pre-dilatation. However, during the procedure, there was a resistance encountered. After the balloon was inflated three times at 15 atmospheres for 60 seconds, the lesion was checked under fluoroscopy and an early recoil was observed. The device was tried to cross again however, it was noted that rewrap of the balloon was not good and the device had difficulty crossing the lesion again. The procedure was competed with another of the same 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).
 
Event Description
It was reported that vessel spasm occurred. The 90% stenosed target lesion was located in a moderately tortuous, moderately calcified shunt. A 5. 0-4/4t/90 mm symmetry¿ balloon catheter was advanced for pre-dilatation. However, during the procedure, there was a resistance encountered. After the balloon was inflated three times at 15 atmospheres for 60 seconds, the lesion was checked under fluoroscopy and an early recoil was observed. The device was tried to cross again however, it was noted that rewrap of the balloon was not good and the device had difficulty crossing the lesion again. The procedure was competed with another of the same device. No patient complications were reported and the patient's status was good.
 
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Brand NameSYMMETRY¿
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key6974087
MDR Text Key109133704
Report Number2134265-2017-10453
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
PMA/PMN Number
K953602
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/24/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/25/2020
Device Model NumberM001103320
Device Catalogue Number10-332
Device Lot Number20694653
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/11/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/01/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/06/2017
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: 10/24/2017 Patient Sequence Number: 1
Treatment
EVEREST INFLATION DEVICE; GUIDE WIRE: KYOUSHA 18 180CM; INTRODUCER SHEATH: TERUMO 5FR
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