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

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

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.

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.

• Brand Name: SYMMETRY¿
• Type of Device: CATHETER, 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 Key: 6974087
• MDR Text Key: 90124014
• Report Number: 2134265-2017-10453
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K953602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/25/2020
• Device Model Number: M001103320
• Device Catalogue Number: 10-332
• Device Lot Number: 20694653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/04/2017
• Initial Date FDA Received: 10/24/2017
• Supplement Dates Manufacturer Received: 11/01/2017
• Supplement Dates FDA Received: 11/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: EVEREST INFLATION DEVICE; GUIDE WIRE: KYOUSHA 18 180CM; INTRODUCER SHEATH: TERUMO 5FR
• Patient Outcome(s): Other