MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE EMERGE¿; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number H7493919315200

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/26/2017

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).Returned product consisted of an emerge balloon catheter.The balloon was loosely folded.The outer shaft, inner shaft, balloon and tip were microscopically examined.There are numerous hypotube and shaft kinks.The inner shaft is stretched in numerous locations.The inner shaft is buckled 2mm from the bi-component weld.There is an inner shaft puncture hole 13.5mm from the bi-component weld along with shaft buckling.There is an outer shaft puncture hole 1mm from the bi-component weld.The damage is consistent with the damage that is seen caused by use of a guidewire.Functional testing was completed using a thruway.014 guidewire, as the guidewire used in the clinical event was not returned for analysis.The thruway guidewire was inserted through the distal tip and could not advance due to the damage.There was no evidence of any material or manufacturing deficiencies contributing to the damage and the reported difficulty.The investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event.(b)(4).

Event Description

Reportable based on analysis completed on 19-jan-2018.It was reported that difficulty loading the wire occurred.A 2.00mm x 15mm emerge¿ balloon catheter was selected for use and while preparing the balloon, it was not possible to get the balloon on the guidewire.A new balloon was used to complete the procedure and everything went well.The patient status was stable.However returned device analysis revealed an outer shaft puncture hole consistent with the damage that is seen caused by use of a guidewire.

• Brand Name: EMERGE¿
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, 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: 7270215
• MDR Text Key: 100147177
• Report Number: 2134265-2018-00910
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• PMA/PMN Number: K113220
• 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
• Report Date: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/16/2020
• Device Model Number: H7493919315200
• Device Catalogue Number: 39193-1520
• Device Lot Number: 21151066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2017
• 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