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

Model Number H74939032504080

Device Problem Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Date 10/31/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that air was present in the balloon.A 5.0mmx40mmx80cm (4f) sterling¿ balloon catheter was selected for use to dilate the lesion.However, during preparation, when air removal was performed, there was an air present on the proximal side of the balloon.The procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a sterling balloon catheter.The balloon was loosely folded.There is contrast media in the balloon and in the inflation lumen.The presence of contrast media in the lumen is indicative of handling beyond simply unpackaging the device.The outer shaft, inner shaft, balloon and tip were microscopically examined.Inspection of the device presented no damage or irregularities.Functional testing was carried out by attaching an inflation device filled with water to the hub of the complaint device, and inflating the device to rated burst pressure.The sterling device inflated and held pressure for 5 minutes without leaking.There was no evidence of any material or manufacturing deficiencies contributing to the reported event.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 air was present in the balloon.A 5.0mmx40mmx80cm (4f) sterling¿ balloon catheter was selected for use to dilate the lesion.However, during preparation, when air removal was performed, there was an air present on the proximal side of the balloon.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: 7039591
• MDR Text Key: 93069183
• Report Number: 2134265-2017-11304
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/31/2017

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: 07/20/2020
• Device Model Number: H74939032504080
• Device Catalogue Number: 39032-50408
• Device Lot Number: 0020917982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2017
• Initial Date FDA Received: 11/16/2017
• Supplement Dates Manufacturer Received: 11/17/2017
• Supplement Dates FDA Received: 12/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2017
• 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