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

Model Number H74939031602210

Device Problems Occlusion Within Device (1423); Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Thrombosis (2100); Obstruction/Occlusion (2422)

Event Date 01/23/2015

Event Type  Injury  

Event Description

It was reported that no flow occurred.The target lesion was 100% in-stent restenosis and thrombosis of a non-bsc stent located in a moderately tortuous and moderately calcified superficial femoral artery.A 6.0mmx220mmx150cm sterling¿ balloon catheter was advanced.Following dilatation, blood flow was improved and the device was removed.After a while, however, it was noted that there was an absence of blood flow at the lesion and below the knee.The physician attempted to reinsert the device via a guide wire to perform another dilation however the physician felt something was wrong with the device.The device was exchanged to a 5mmx150mm sterling¿ balloon catheter and the procedure was continued.No further patient complications were reported and the patient's status was good.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).Device evaluated by mfr: returned device consisted of a sterling balloon catheter with no other devices.There was contrast in the inflation lumen.Inspection under magnification revealed a hole in the inner shaft within the balloon 26mm from the tip.The diameter of the hole was consistent with a diameter of a guidewire.There were several kinks throughout the inner shaft within the balloon.There were no irregularities throughout the inner shaft material that could have contributed to the hole.The distal tip was damaged.There was no evidence of any product quality deficiencies contributing to the damage.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).

Event Description

It was further reported that following dilation using a 6.0mmx220mmx150cm sterling¿ balloon catheter, thrombosis was resolved however thrombosis was again noted, which contributed to no flow.The physician attempted to reinsert the device via a guide wire to perform another dilation however the balloon ruptured.After the device was exchanged to a 5mmx150mm sterling¿ balloon catheter, no flow and thrombosis were resolved.

• 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: 4515854
• MDR Text Key: 5534510
• Report Number: 2134265-2015-00585
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K141150
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2016
• Device Model Number: H74939031602210
• Device Catalogue Number: 39031-60221
• Device Lot Number: 17457679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2014
• 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: GUIDE WIRE: CRUISE; INFLATION DEVICE: ENCORE
• Patient Outcome(s): Required Intervention