MAUDE Adverse Event Report: CONTRACT MEDICAL INTERNATIONAL GMBH BIOTRONIK FORTRESS INTRODUCER SHEATH SYSTEM, 45CM, 6F STRAIGHT

Model Number FG-06551-001A

Device Problems Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2018

Event Type  malfunction  

Manufacturer Narrative

The root cause of the incident is unknown at the time of the initial report.The complaint device was not returned for evaluation yet, therefore the investigation and root cause analysis could not be performed.The dhr review of the complaint lot 645007 and related subassemblies lots 646116 and 646115 was performed, there was no deviation found in the records.The devices passed all 100% in process and aql based qc inspections.The manufacturer informed manufacturing operators and qc inspectors about the complaint.No remedial actions were initiated at the time of initial report due to the suspected user error (withdrawal of introducer when resistance was felt) and / or the incident could be related to the patient condition/anatomy based on results of investigations performed within the previous complaints.Additionally, a vessel spasm (which could be a potential cause of the resistance) can occur during the procedure, as defined under the potential complications section in ifu.(b)(4).

Event Description

The manufacturer was informed, that during removal of the sheath, there was a resistance.The sheath started to elongate and then came apart about 10 cm from the hub.The artery forceps were used to remove the rest of the sheath and nothing was left in the patient.

• Brand Name: BIOTRONIK FORTRESS INTRODUCER SHEATH SYSTEM, 45CM, 6F STRAIGHT
• Type of Device: INTRODUCER SHEATH
• Manufacturer (Section D): CONTRACT MEDICAL INTERNATIONAL GMBH; lauensteiner strasse 37; dresden, germany 01277 ; GM 01277
• Manufacturer (Section G): CONTRACT MEDICAL INTERNATIONAL GMBH; lauensteiner strasse 37; dresden, germany 01277 ; GM 01277
• Manufacturer Contact: jan kloboucnik ; lauensteiner strasse 37; dresden, germany 01277 ; GM 01277
• MDR Report Key: 7925464
• MDR Text Key: 122639216
• Report Number: 3003637635-2018-00002
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 04251244500078
• UDI-Public: 04251244500078
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K153197
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/02/2018

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: 01/31/2021
• Device Model Number: FG-06551-001A
• Device Catalogue Number: 386594
• Device Lot Number: 645007
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2018
• Initial Date FDA Received: 10/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2018
• 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 Outcome(s): Other
• Patient Age: 63 YR