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

Model Number H74939031354010

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/15/2017

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.  (b)(4).

Event Description

It was reported that radiopaque (ro) marker bands were not visible under fluoroscopy.The target lesion was located in a carotid artery.After placement of a guide catheter and distal protection device in the target area, a 3.5mmx40mmx135cm (4f) sterling¿ balloon catheter was advanced for pre-dilation.Inflation was performed at the target area using indeflator, however, it could not be confirmed at all in the image.The device was removed, and preparation was performed again.When it was checked by fluoroscopy outside the body, still it could not be seen.It could not be seen even though the contrast media was 100%.The procedure was completed with a different device without problems.No patient complications nor injuries were reported.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a sterling balloon catheter with an unidentified stop cock attached to the hub.The balloon was loosely folded.The outer shaft, inner shaft, balloon and tip were microscopically examined.The tip is damaged.Inspection of the remainder of the device presented no other damage or irregularities.The markerbands are visible and are in the correct location.There was no evidence of any damage or irregularities contributing to the reported difficulty.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).

Event Description

It was reported that radiopaque (ro) marker bands were not visible under fluoroscopy.The target lesion was located in a carotid artery.After placement of a guide catheter and distal protection device in the target area, a 3.5mmx40mmx135cm (4f) sterling¿ balloon catheter was advanced for pre-dilation.Inflation was performed at the target area using indeflator, however, it could not be confirmed at all in the image.The device was removed, and preparation was performed again.When it was checked by fluoroscopy outside the body, still it could not be seen.It could not be seen even though the contrast media was 100%.The procedure was completed with a different device without problems.No patient complications nor injuries 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: 6915090
• MDR Text Key: 88228229
• Report Number: 2134265-2017-09853
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K053118
• 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,Followup
• Report Date: 09/18/2017

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: 05/31/2019
• Device Model Number: H74939031354010
• Device Catalogue Number: 39031-35401
• Device Lot Number: 19229586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/18/2017
• Initial Date FDA Received: 10/05/2017
• Supplement Dates Manufacturer Received: 11/28/2017
• Supplement Dates FDA Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2016
• 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