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

Model Number H74939349140

Device Problems Tear, Rip or Hole in Device Packaging (2385); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/19/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the complaint device was not received for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

It was reported that a seam tear occurred.A 14 f isleeve introducer sheath was inserted.Following withdrawal of the isleeve, it was noted that one seam had split.The seam split did not compromise the performance of the isleeve or cause any issue to the patient.This product is only ous approved but it is similar to an approved us device.

Manufacturer Narrative

(b)(4).Device evaluated by mfr: investigation conclusion corrected from "the investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited" to "the complaint investigation conclusion code assigned was ¿device not returned¿.It is notable that there is no evidence of any specification non-conformances related to the complaint device." (b)(4).

Event Description

It was reported that a seam tear occurred.A 14 f isleeve introducer sheath was inserted.Following withdrawal of the isleeve, it was noted that one seam had split.The seam split did not compromise the performance of the isleeve or cause any issue to the patient.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: 7519097
• MDR Text Key: 108439969
• Report Number: 2134265-2018-04030
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2018
• 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: 0021808208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2018
• 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