MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE SUPER SHEATH INTRODUCER SHEATH; INTRODUCER, CATHETER

Model Number M00115962B1

Device Problem Material Perforation (2205)

Patient Problem Hematoma (1884)

Event Date 06/13/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 perforated sheath and hematoma occurred.A 6fr x 11 cm n/g super sheath introducer sheath was selected for use.During procedure, it was noticed that the sheath became perforated.Furthermore when the intervention was started, a large hematoma was also noticed.A puncture was performed to address the hematoma.The medical intervention was lengthen for important monitoring of the patient.No further complications reported.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.Only the sheath was returned.A scratch that seemed to be made by a sharp object's touching the sheath was found, a hole that was made by the scratch that was found on the root portion of the sheath.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical/procedural factors.(b)(4).

Event Description

It was reported that perforated sheath and hematoma occurred.A 6fr x 11cm n/g super sheath introducer sheath was selected for use.During procedure, it was noticed that the sheath became perforated.Furthermore when the intervention was started, a large hematoma was also noticed.A puncture was performed to address the hematoma.The medical intervention was lengthen for important monitoring of the patient.No further complications reported.

• Brand Name: SUPER SHEATH INTRODUCER SHEATH
• 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: 6755182
• MDR Text Key: 81440918
• Report Number: 2134265-2017-07585
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K060190
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: M00115962B1
• Device Catalogue Number: 15-962B
• Device Lot Number: 16H05B6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2017
• Initial Date FDA Received: 07/31/2017
• Supplement Dates Manufacturer Received: 10/16/2017
• Supplement Dates FDA Received: 10/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2016
• 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
• Patient Outcome(s): Required Intervention