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

Model Number H74939032252210

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/25/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that shaft break occurred.A 2.5x220x150 (4f) sterling¿ balloon catheter was advanced for dilation.However, it was noticed that there was a broken area right after the second balloon marker which prevented the device to advance through the guide catheter.The procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr.: the returned product consisted of a sterling balloon catheter.The balloon was loosely folded.The shaft is intact and is not broken.The outer shaft, inner shaft, balloon and tip were microscopically examined.The shaft is kinked 2mm from the proximal balloon weld.The proximal markerband is flattened/damaged.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.There was no evidence of any material or manufacturing deficiencies contributing to the damage.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 break occurred.A 2.5x220x150 (4f) sterling balloon catheter was advanced for dilation.However, it was noticed that there was a broken area right after the second balloon marker which prevented the device to advance through the guide catheter.The procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: STERLING¿
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6812866
• MDR Text Key: 83515711
• Report Number: 2134265-2017-08260
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K141112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/07/2018
• Device Model Number: H74939032252210
• Device Catalogue Number: 39032-25221
• Device Lot Number: 20752138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2017
• 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