MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE ISLEEVE 14F; INTRODUCER, CATHETER

Model Number H74939349140

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/25/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the complaint device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The complaint investigation conclusion code assigned was 'device not returned'.(b)(4).

Event Description

It was reported that air was introduced into the system.A 14 f isleeve introducer sheath was selected.No air was noted to be present during preparation.The isleeve was inserted; however, the device would not initially advance due to the transition point.The dilator was used to dilate the vessel.Air was noted in the hub of the isleeve due to the removal and reintroduction of the dilator from the sheath at the operating table.No patient complications were reported and the patient's status is ok.This product is only ous approved but it is similar to an approved us device.

• Brand Name: ISLEEVE 14F
• Type of Device: INTRODUCER, CATHETER
• 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: 7542766
• MDR Text Key: 109231491
• Report Number: 2134265-2018-04355
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: NA
• 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: 04/25/2018

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: 03/01/2019
• Device Model Number: H74939349140
• Device Lot Number: 0021808207
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2018
• Initial Date FDA Received: 05/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2018
• 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
• Patient Age: 85 YR