MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE STERLING¿; CATHETER, PERCUTANEOUS

Model Number H74939032601080

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/08/2015

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).Device evaluated by mfr.: the returned device consisted of a sterling catheter plus an unidentified wire.The balloon was loosely folded and there was blood and contrast in the device.There was damage to the balloon, shaft and tip of the device.The inner shaft and distal markerband were located outside of the balloon (tied/knotted with balloon).Microscopic inspection revealed the distal portion of the balloon was tied in a knot with additional holes visible in the balloon.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.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-nov-2015.It was reported that balloon malfunction occurred.The target lesion was located in the moderately tortuous and moderately calcified artery in the right forearm shunt.A 6.0mmx100mmx80cm hybrid sterling balloon catheter was selected for use and advanced to dilate the lesion.However, during the procedure, the balloon section was "bound".The procedure was completed with this device.No patient complications were reported and the patient's status was good.However, returned device analysis revealed balloon hole/ perforation.

• Brand Name: STERLING¿
• Type of Device: CATHETER, PERCUTANEOUS
• 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: 5276684
• MDR Text Key: 32988374
• Report Number: 2134265-2015-08288
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K053116
• 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
• Report Date: 11/12/2015

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 Expiration Date: 01/31/2018
• Device Model Number: H74939032601080
• Device Catalogue Number: 39032-60108
• Device Lot Number: 17592699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/12/2015
• Initial Date FDA Received: 12/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2015
• 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