MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE ROTALINK¿ PLUS; CATHETER, CORONARY, ATHERECTOMY

Model Number H749236310020

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/28/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the device was not returned for analysis.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors. (b)(4).

Event Description

It was reported that shaft leak occurred.The target lesion was located at the mid left anterior descending artery.A 1.25mm rotalink plus was selected for use.During the procedure, it was noted that there was a small puncture on the shaft and was leaking rotaglide.The operating team continued with the procedure and covered the puncture with there fingers to prevent further leaking.The procedure was completed with this device.No patient complications were reported and the patients' status was fine.

• Brand Name: ROTALINK¿ PLUS
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5823368
• MDR Text Key: 50516770
• Report Number: 2134265-2016-06621
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H749236310020
• Device Catalogue Number: 23631-002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/01/2016
• Initial Date FDA Received: 07/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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