MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) ROTAWIRE¿ AND WIRECLIP¿ TORQUER; CATHETER, CORONARY, ATHERECTOMY

Model Number H802228240022

Device Problems Kinked (1339); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/06/2017

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).The device was returned for analysis.Visual inspection revealed that the device has the body kinked and the distal tip unraveled.Also, the core wire was broken in two sections.The first break starts at 329 cm from proximal end.And the segment of the wire that is completely detached is inserted into the proximal section of the spring tip and measures approximately 1 cm.Both sections complete the 330 cm that the wire should measure.The overall length and outer diameter of the distal tip could not be measured due to the distal tip was unraveled.The outer diameter of the proximal and middle section were within specification.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

Reportable based on device analysis completed on 12-jul-2017.It was reported that difficulty tracking over the rotawire and a kinked wire occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified proximal left anterior descending (lad) artery.A 330cm rotawire¿ was selected for use.During procedure, the rotawire was advanced to the target lesion and a 2.0mm rotalink burr was advanced; however, the physician felt that it was caught inside the guiding catheter.The physician had to remove the burr along with the rotawire.The target lesion was again crossed with another non bsc guidewire and was replaced with the same rotawire using a non-bsc microcatheter.However, when the non-bsc microcatheter was removed, resistance was encountered.When this device was checked after removing from the patient's body, it was noted that the wire was damaged/kinked.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was good.However, device analysis revealed that the core wire was broken in two sections.

• Brand Name: ROTAWIRE¿ AND WIRECLIP¿ TORQUER
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6757449
• MDR Text Key: 81510574
• Report Number: 2134265-2017-07440
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729195566
• UDI-Public: (01)08714729195566(17)20181010(10)20389696
• Combination Product (y/n): N
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/10/2018
• Device Model Number: H802228240022
• Device Catalogue Number: 22824-002
• Device Lot Number: 20389696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2017
• 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: GUIDEWIRE: GUIDEWIRE14; MICRO GUIDE CATHETER: FINECROSS (TERUMO)