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

Model Number	FG-06551-001A
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/25/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: INTRODUCER SHEATH
• Manufacturer (Section D): CONTRACT MEDICAL INTERNATIONAL GMBH; lauensteiner strasse 37; dresden, germany 01277 ; GM 01277
• MDR Report Key: 7925464
• Report Number: 3003637635-2018-00002
• Device Sequence Number: 11330229
• Product Code: DYB
• UDI-Device Identifier: 04251244500078
• UDI-Public: 04251244500078
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K153197
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2018
• Initial Report FDA Received Date: 10/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR