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

Model Number H802228240022

Device Problems Detachment Of Device Component (1104); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/24/2018

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).

Event Description

Same case as mdr id: 2134265-2018-05607.It was reported that the rotawire tip became stuck in lesion, detached and remained inside patient's body.The 75% stenosed target lesion was located in the moderately tortuous and moderately calcified proximal left circumflex artery.A 330 cm rotawire¿ and a rotaburr were selected for use.During the procedure, after adjusting the rotational speed, the rotaburr was delivered inside patient's body and ablation was performed.The rotaburr was removed after ablation; however, the rotawire became slightly separated.Also, the ro marker of rotawire tip remained in the peripheral blood vessel.Furthermore, it was noted that the detached portion of the rotawire was stretched due to a possibility that the tip became trapped in the vessel.According to the physician, the detached tip remained in the peripheral artery with no particular adverse effect to the patient.The physician decided to perform follow-up observation to the patient.The procedure was completed with another of the same device.No further patient complications were reported.

Event Description

Same case as mdr id: 2134265-2018-05607.It was reported that the rotawire tip became stuck in lesion, detached and remained inside patient's body.The 75% stenosed target lesion was located in the moderately tortuous and moderately calcified proximal left circumflex artery.A 330cm rotawire¿ and a rotaburr were selected for use.During the procedure, after adjusting the rotational speed, the rotaburr was delivered inside patient's body and ablation was performed.The rotaburr was removed after ablation; however, the rotawire became slightly separated.Also, the ro marker of rotawire tip remained in the peripheral blood vessel.Furthermore, it was noted that the detached portion of the rotawire was stretched due to a possibility that the tip became trapped in the vessel.According to the physician, the detached tip remained in the peripheral artery with no particular adverse effect to the patient.The physician decided to perform follow-up observation to the patient.The procedure was completed with another of the same device.No further patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr.: the device was returned for analysis.Visual inspection of the device revealed that the device has several kinks along its body and another one on its distal tip.Also presents its distal tip fractured, stretched and unraveled.Dimensional inspection of the overall length and outer diameter (od) of the distal tip could not be performed due to the device condition.The od of the middle and proximal section of the device were within specification.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 & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

• 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
• MDR Report Key: 7613251
• MDR Text Key: 111449230
• Report Number: 2134265-2018-05598
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729195566
• UDI-Public: 08714729195566
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 05/25/2018

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: 02/12/2020
• Device Model Number: H802228240022
• Device Catalogue Number: 22824-002
• Device Lot Number: 21733307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2018
• Initial Date Manufacturer Received: 05/25/2018
• Initial Date FDA Received: 06/19/2018
• Supplement Dates Manufacturer Received: 07/04/2018
• Supplement Dates FDA Received: 07/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other